Rapid, Sensitive NGS based Chimerism Monitoring with Oxford Nanopore Sequencing

We are excited to announce the prototype launch of ONtrack! ONtrack is an in-development solution designed to enable rapid and sensitive chimerism monitoring using ONT platforms.

Based on the well-established NGStrack assay, ONtrack uses the same 34 biallelic indel markers and integrates seamlessly into the ONT sequencing workflow.

When to choose ONtrack for Chimerism Monitoring?

ONtrack delivers a cost-effective, rapid, and highly sensitive alternative to traditional Illumina-based chimerism assays with the flexibility and scalability of Oxford Nanopore Technologies sequencing. This is the perfect solution for laboratories that need urgent or time-sensitive results.

Key advantages:

• Fast sequencing: Get results in under 3 hours per sample

• Easy workflow: Less than 2h hands on time required

• High throughput: Process up to 96 samples in a single run

• Enhanced sensitivity: Detect chimerism levels with sensitivity down to 0.5%

• Integrated up-to-date data analysis: Compatible with the latest version of TRKengine software

Flexible & Scalable alternative to Illumina-based workflows

ONtrack uses 34 bi-allelic indel markers and combines rapid, scalable ONT sequencing with streamlined analysis in TRKengine®.

DNA to results turnaround time of less than 3 hours per sample 

Ready to start using ONtrack?

Explore the potential of our prototype and take the next step in Chimerism Monitoring.

Order a Prototype

As the festive season approaches, we would like to thank all our customers, partners, and collaborators for their continued trust and commitment throughout the year. We are looking forward to another successful year together in 2026!

Order timelines for the holiday period

If you wish to take advantage of the current 2025 prices, we encourage you to place any remaining orders before 31 December.

If you would like to receive your order before our holiday closure (subject to stock availability), please place your order before*:

• 16 December for Europe

• 15 December for Rest of World (ROW)

Orders placed after the above dates will be processed during the week of 5 January.

*Shipments requiring commercial airfreight are excluded from the schedule above.

Support during the holidays

While our offices are closed from December 25th to January 1st, our support team remains available for urgent cases at prioritysupport@gendx.com.

Warm holiday wishes from the entire GenDx team!

We appreciate your collaboration and look forward to supporting you again in the new year!

We are pleased to confirm that our NGSgo® solutions have been validated on the new Illumina MiSeq™ i100 System. The findings confirm that laboratories using these NGSgo products can confidently transition to the MiSeq i100 System without changing their established workflows or data quality expectations.

Which products have been tested and validated on MiSeq i100 System?

• NGSgo-MX11-3

• NGSgo-ProntoAmp

• NGSgo-MX6-1

• NGSgo-AmpX v2

• NGSgo-AmpX v3
  All tests were performed using the NGSgo-Library Full Kit (LFK).

Main conclusions

• GenDx NGSgo workflows deliver high-quality sequencing data and robust typing concordance on the MiSeq i100 System.

• The MiSeq i100 System produces high Q30, shorter runtimes (~7 hours) and increased usable output, enabling larger batch sizes while maintaining GenDx quality standards.

📄 Read the full validation Technical Note
Download: Compatibility of NGSgo products with the MiSeq^TM i100 System

Updated documentation:

• IFU NGSgo Sequencing MiSeq i100 2012003 edition 1, 2025-11 (new)

• NGSgo Workbook Illumina, edition 19, 2025 (updated)
  These documents are also available on our Downloads page.

If you have questions about migrating your workflow, please contact our Technical Support team at support@gendx.com.

When an organ becomes available, transplant teams are under pressure to act fast, but accuracy in matching is equally critical. Today, most deceased donor HLA typing is still performed at intermediate resolution, which can limit certainty when ruling out donor-specific antibodies (DSAs). As a result, the ability to use virtual crossmatching may be restricted, ultimately slowing down organ allocation for highly-sensitised recipients.

High-resolution typing across HLA loci could help overcome this challenge by bringing typing resolution in line with how HLA antibodies are defined. If performed quickly enough, this could support more confident decision-making and improve the chance that suitable organs are accepted in time.

In our upcoming webinar, Lizzy Russell-Lowe, Clinical Scientist at Manchester Royal Infirmary, will present a study in which HLA typing results obtained with the GenDx NGS-Turbo® kit, using Oxford Nanopore Technologies sequencing, were retrospectively compared with standard intermediate-resolution HLA typing methods. The NGS-Turbo^® kit produced concordant typing results for all samples in less than 4 hours.

• Can high-resolution typing be delivered fast enough for deceased donor timelines?

• Could it help reduce reliance on wet crossmatching?

• What might the potential benefits be for highly-sensitised patients?

Learn more in our webinar!

The promising results of the study will be discussed in detail during our upcoming webinar:

NGS-Turbo® is currently available as RUO. Find out more about the product here

In September, the month of the World Marrow Donor Day, GenDx organized their ‘Fit to Donate’ initiative.

Since 2018, GenDx has partnered with Matchis, the Dutch Center for Stem Cell Donors. The goal is to raise awareness about stem cell transplantation among young, healthy potential donors in and around Utrecht. This aligns with GenDx’s mission to improve the quality of life and survival chances of transplant patients. This year, the focus shifted to raising funds for Matchis.

You probably heard on the news that there is a need for more potential stem cell donors. This increases the chances of finding a life-saving match for all patients needing a stem cell transplant. Each new donation represents hope to get a second chance at life.

Did you know that it costs Matchis €35,- to type and register one single potential stem cell donor in the international database? With an aimed growth of 20,000 new registrations per year, this represents a significant expense. To cover these costs, Matchis largely relies on sponsorships and donations. That’s why GenDx decided to start a campaign on SterkvoorMatchis.nl, Matchis’ fundraising platform.

To support this ‘Sterk voor Matchis’ campaign, GenDx organized the ‘Fit to Donate’ initiative during the month of September. This culminated in the ‘GenDx Tulip Run’ on September 23. Inspired by previous “Tulip Runs” held during Immunogenetics conferences, this event brought together GenDx colleagues, friends, and family. Everyone was motivated to run or walk at Utrecht Science Park by a shared goal.

Our colleagues really went the extra mile in September. We look back on an amazing day filled with teamwork, laughter and a healthy sense of competitiveness. We raised an impressive € 3.850,- for Matchis – symbolizing one newly registered stem cell donor for each GenDx employee.

Learn more about the initiative at GenDx.com/stem-cell-donation/

Single Locus HLA typing to maximize flexibility on ONT

We are excited to announce the prototype launch of NGSgo-ProntoFLX! Designed as a ready-to-use amplification mixture optimized for Oxford Nanopore Technologies sequencing platforms. NGSgo-ProntoFLX supports both singleplex and duplex workflows, delivering a fast, flexible, and easy solution to your workflow.

Key advantages:

• Fast sequencing: Achieve results in just 10 minutes per sample

• Comprehensive coverage: Full-gene amplification for accurate analysis

• High-quality data: Ensures reliable and reproducible results

• High throughput: Process up to 96 samples

• Integrated data analysis: Compatible with NGSengine software

• Prototype availability: HLA-A, HLA-B, HLA-DQA/DQB duplex

Flexibility to repeat specific loci amplifications

NGSgo-ProntoFLX is the perfect solution for when you need to prioritize depth of coverage and read length for a single sample, making it ideal for repeating analysis on a specific locus or when the highest quality data is needed. 

Turnaround time DNA to results

Ready to start using NGSgo-ProntoFLX?

Explore the potential of our prototype and take the next step in HLA sequencing.

Order a Prototype

For more information, visit our product page.

We are excited to announce that the new NGS-Turbo barcoded format is now available.

Whether you are looking to comply with ASHI standards or improve your laboratory process, the new version of NGS-Turbo is designed to effectively exclude residual DNA. In this update, the new version of NGS-TurboPrep replaces the previous version.

What are the benefits?

• ASHI standards compliance
• Improved design
• Same ONT reagents as NGS-Pronto
• Excellent data quality
• Cost-efficient ONT reagents
• Option to combine multiple samples on one flow cell

What’s new in the protocol?

The updated NGS-TurboPrep protocol includes a barcode mix and requires different ONT reagents (EXP-NBA114 instead of SQK-LSK114). The turnaround time increases by approximately 2 minutes. All other steps in the protocol remain the same.

About NGS-Turbo

With a turnaround time of less than three hours (single sample) and an easy and robust workflow, NGS-Turbo is designed for HLA typing in situations where time is a critical factor. Learn more about NGS-Turbo via the link.

If you have any questions or need assistance, please feel free to reach out to us at portfolio@gendx.com or contact your Sales rep.

Contact our Sales Team

We are happy to announce that GenDx is supporting ASHI 2025 with a Platinum sponsorship! The conference will be held this year from Monday October 6 to Friday, October 10.
Make sure to join us in our activities!

Teaching Session

Monday, October 6, 2025 | 9:00am – 4:30pm| Hyatt Regency Grand Cypress

Join our training and become an expert in HLA typing. Join us for an HLA typing training featuring our latest updates and innovations.

More information and registration here

Tulip Run

Wednesday, October 8, 2025 | 6:30am – 7:30am | Hyatt Regency Grand Cypress

Walk or run to this event, sponsored by GenDx, and join us on the common goal: enhancing the outcome of transplantation. Proceeds from this event will benefit a local OPO in Orlando, FL. All runners and walkers are welcome. Don’t forget to add the run to your meeting registration!

More info about the event here.

Find photos from previous Tulip Run events here

User Group Meeting: 20 Years of Advancing Transplantation, One Typing at a Time

Wednesday, October 8, 2025 | 1:40pm – 2:35pm | Grand Cypress Ballroom G-I

Speakers:

Maarten Penning, PhD
General Manager GenDx

Eszter Lazar-Molnar, Ph.D., D(ABMLI), F(ACHI)
Associate Professor, Department of Pathology
University of Utah and Director, Histocompatibility&Immunogenetics Laboratory

James H Lan, MD, FRCP(C), F(ACHI)
Assistant Professor (tenure-track)
University of British Columbia and Director, Immunology Laboratory

Posters 

Our posters will be available online on the ASHI platform.

Looking forward to meeting you!
For more information and registration at ASHI, visit https://www.ashi-hla.org/

NGSgo®-ProntoAmp has officially received IVD certification

We are proud to announce that NGSgo-ProntoAmp has officially received IVD certification under the European In Vitro Diagnostic Regulation (EU) 2017/746. This important milestone reflects our ongoing commitment to providing high-quality, compliant, and future-proof solutions for HLA typing.

Interested? Feel free to reach out to your Sales representative, or contact us directly at support@gendx.com.

About the NGS-Pronto® 

• Amplification & barcoded library preparation
• DNA to results < 8h
• Up to 96 samples per run

Complete solution for Oxford Nanopore sequencing. NGSgo-ProntoAmp offers amplification of 11 HLA loci using a whole-gene approach, resulting in at least a 3-field resolution. NGS-ProntoPrep offers a complete barcoded library preparation for sequencing on ONT devices.

The NGSgo-ProntoAmp amplification is also compatible with the NGSgo Library Full Kit for sequencing on Illumina systems!

Learn more about NGS-Pronto via the link.

If you have any questions or need assistance, please feel free to reach out to us at portfolio@gendx.com or contact your Sales rep.

We are happy to announce that on 3-5 September, 2025, GenDx will be present at DGI 2025 conference in Frankfurt, Germany.

GenDx is proud to be exhibiting at the 32. Jahrestagung der Deutschen Gesellschaft für Immungenetik (DGI), where experts come together to advance transplant field.  Please join us at Booth #6 to discover the latest in molecular transplant diagnostics and engage with our expert team to get your questions answered.

Attend GenDx events:

4 September Industry Symposium –  The Future of HLA Typing: Speed and Precision with NGS-Pronto®

• • 12:30 – 13:15
  • Join us for an engaging symposium to explore the future of multiplexed, whole-gene HLA sequencing with NGS-Pronto, using Oxford Nanopore Technologies. Dr. rer. nat. Melanie Gerth, Labor Transplantationsimmunologie, Wissenschaftliche Mitarbeiterin from Universitätsklinikum Jena will share her hands-on experience with NGS-Pronto, offering valuable insights into the practical applications and benefits. Additionally, we will highlight the latest results from the NGS-Pronto clinical study and discuss exciting new developments.

5 September – GenDx Tulip Run

• • 7:00 – 8:00
  • Ready to run? This year GenDx is organizing a 3km Tulip Run at DGI. Register directly at the GenDx booth and get your t-shirt and a special prize at the end!

Meet the team and discover our latest innovations in transplantation:

• Antje Nissen – Sales & Application Specialist
• Kira Takun MSc – Sales & Application Specialist
• Nina Klein PhD –  International Product Manager Transplant

See you in Frankfurt!

Now available!

GenDx proudly presents NGSengine 4.0. In this new version we introduce a range of new and enhanced features to support your analysis needs.

NGSengine 4.0 is able to analyze ONT data. A functionality that was previously available through NGSengine-Turbo. Additionally, a new automated analysis feature will replace NGSignition, enabling automatic initiation of analysis immediately after sequencing.

What’s new?

• • Expanded sequencing compatibility – Analyze data from Illumina, Ion Torrent, PacBio, and ONT in one software product.
  • Flexible analysis profiles – Use optimized, predefined settings for each amplification strategy and platform, or create your own custom profiles to match your lab’s workflow.
  • Automated analysis – Set the software to monitor designated folders and automatically start analysis when new data arrives.
  • Compatibility with Windows 11 – The software is fully validated for use with Windows 11.
  • IMGT update – Stay up to date with the latest reference data.
  • Usability improvements & Bug fixes – Enhancements to streamline your workflow.

Interested to try out NGSengine version 4?

➡️Download the new version here

➡️Read the release note here

We are happy to announce that on 2-5 August, 2025, GenDx will be present at WTC conference in San Francisco, US.

GenDx is proud to be exhibiting at the 2025 World Transplant Congress, where global experts come together to advance transplant medicine.  Please join us at Booth #1010 to discover the latest in molecular transplant diagnostics and engage with our expert team to get your questions answered.  You also will have the opportunity to pick up exclusive GenDx giveaways!

As pioneers in transplant diagnostics, we’re committed to supporting laboratories and clinicians with tools that improve and streamline transplant outcomes.
See you in San Francisco!

Meet the GenDx team and discover our latest innovations in transplantation:
🔸 Michael Mignogno – Director of Sales | North America
🔸 Andrew Meyers – Sr Sales & Application Specialist & Education Manager | North America
🔸 Dan Mancuso – Commercial Business Development Manager | North America
🔸 Pascal van der Weele – Associate Director R&D
🔸 Eline ter Steege – Project Manager R&D

We are happy to announce that on March 23-25, 2025, GenDx will be present at EWIC conference in Warsaw, Poland.

If you are interested in learning about our latest products make sure to visit our booth#10 and talk with our sales representative Jan Duiker, VP Distribution Sale or Panos Antoniadis, field application specialist.

Lunch Symposium | Tuesday, March 25

This year, we celebrate 20 years of GenDx and two decades of dedication to transplant diagnostics. What began as a small team of scientists with a shared vision has grown into a globally recognized leader, driven by innovation, collaboration, and a commitment to improving the quality of life and survival of transplant patients.

The beginning

On January 1st, 2004, Erik Rozemuller and Wietse Mulder began shaping Genome Diagnostics. After a year of planning, GenDx was officially established on March 1st, 2005. We started as a small team of dedicated scientists working to develop better tools for high-resolution HLA typing. From the beginning, collaboration and education were as important to us as innovation. We knew that true progress in transplantation wouldn’t come from technology alone but also from sharing knowledge with the healthcare professionals who rely on it every day.

Growing with purpose

Over the years, GenDx has evolved, but our core mission has remained the same. In 2013, we introduced NGSgo reagents and NGSengine software, making high-resolution sequencing for HLA typing more accessible to labs worldwide. As our expertise grew, we expanded our focus to include chimerism monitoring with NGStrack and TRKengine, helping transplant teams detect complications earlier.

In 2022, we became part of Eurobio Scientific, a step that allowed us to strengthen our impact globally while remaining true to our values. Today, we are proud to be part of a broader network of diagnostics specialists, with affiliates across Europe and other parts of the world.

A global leader in transplant diagnostics

GenDx is one of the top tier companies in transplant diagnostics worldwide, recognized for our commitment to research, education, and high-quality solutions. We have grown into a team of over 110 colleagues from 20 different nationalities, bringing diverse perspectives and expertise to our work. This would not be possible without the support and commitment from our customers and partners. Today, we collaborate with 40 distributors worldwide and are able to reach hospitals and research centres around the globe.

A few words from our General Manager

“GenDx remains dedicated to advancing the field of transplant diagnostics, building on 20 years of progress. With our talented team and strong partnerships, we are committed to continuing our efforts to improve patient outcomes and make meaningful contributions to the broader transplant community and the Eurobio Scientific Group.”
– Maarten Penning, PhD, General Manager

Prof. dr. Frans Claas

Emeritus Professor of Immunology, Leiden University Medical Center

We are deeply saddened to hear of the sudden loss of Prof. Frans Claas.
As founding member of EFI, Prof. Claas made an immense impact on the field of H&I. His expertise and view were invaluable, and his dedication to sharing knowledge and fostering collaboration played an important role in shaping the HLA community. Prof. Claas was for a long time respected member of our GenDx Scientific Advisory Board and as such a source of inspiration for GenDx, and our founders. His contributions and presence will be deeply missed. Our condolences go out to his family, friends, and colleagues during this sad time.

It is with great sadness that EFI heard about the sudden death of our dear friend and colleague Prof. Frans Claas, aged 73 years. He passed away suddenly on Sunday 2nd February 2025 while on holiday in South Africa.

Frans was a founder member of EFI and a true ambassador for H&I, serving as EFI President between 2002-2004. but he also chaired the Scientific Committee, and edited the EFI Newsletter for many years. Frans also worked tirelessly with Europdonor (Matchis), Eurotransplant, the Dutch Transplantation Foundation, Eurocord and ASHI.

Above all, Frans was supremely generous in sharing his knowledge and expertise worldwide and was a great believer in the strength of international collaboration.

Our thoughts and sincere condolences extend to Frans’s wife, Ilse, and family, also to his colleagues and close friends throughout the world at this difficult time.

Marco Andreani, EFI President
Dave Roelen, EFI Secretary
Kay Poulton, EFI Deputy-Secretary

We are happy to announce that on February 5-7, 2025, GenDx will be present. We will attend the APHIA conference in Bangkok, Thailand.

If you are interested in learning about our latest products or seeing a live demonstration, make sure to visit our booth#A3 and talk with our sales representative Daan ‘t Hart or our general manager Maarten Penning.

Lunch Symposium | Wednesday, February 5

In 2024, one of GenDx’s key objectives was to reduce our environmental impact. To bring this vision to life, a group of seven enthusiastic colleagues came together to form the Sustainability Group. This team is dedicated to identifying opportunities, implementing changes, and inspiring our entire company to contribute to a greener future.

How Sustainability at GenDx Started

Our journey toward sustainability began as a colleague-driven initiative. The growing global focus on environmental issues inspired us to take action. This is a problem that can no longer be ignored, so we set some initial goals, milestones, and formed a dedicated group to make it happen. Today, the Sustainability Group works to implement sustainable practices and track their progress, while also raising awareness across the company.

What Sustainability Means for GenDx
For us, sustainability is not just about “going green.” It’s about taking measurable steps to ensure our operations have a minimal environmental footprint, both in and out of the lab. It’s about finding innovative ways to balance quality with eco-consciousness, inspiring others, and making a meaningful impact on the world.

GenDx’s Green Initiatives
We are proud to share some of the steps we’ve taken so far:
-Reducing Styrofoam usage. We’ve cut down our reliance on Styrofoam shipping boxes by 80%.
-Minimizing paper waste. By switching to digital signatures, reusable notebooks, and reducing printed materials like business cards, we’re cutting back significantly. We’ve even started -tracking printing habits to better understand our usage.
-Recycling gloves. Through the Kimberly-Clark Professional RightCycle program, we aim to recycle 90% of our lab gloves.
-Encouraging sustainable travel. For travel within Europe, we prioritize trains and electric vehicles whenever possible.
-Recycling Nanopore flow cells. Around 80% of the flow cells we purchase are returned to Oxford Nanopore for recycling.
-Repurposing materials. Shipping boxes are made available for employees to reuse, such as for moving.
-Energy efficiency. We’ve installed LED lighting, reducing our energy consumption by 50%.

Why Sustainability Matters
Sustainability holds deep personal meaning for many of us at GenDx. Reflecting on years spent in the lab, one colleague shared: “After years of working in labs, I’ve seen how wasteful the work can be—especially with single-use plastics. I’ve always thought about how we could reduce waste while still maintaining the quality of our work. It’s exciting to see new alternatives, like greener plastics, emerging. Now, it’s all about researching and figuring out what solutions work best for us..”

Simple Sustainable Habits
We believe that even small daily actions can contribute to a larger shift. Some of the habits our team members practice include:
-Shopping at local zero-waste stores with reusable containers.
-Using reusable bags and water bottles.
-Composting food waste and recycling.
-Traveling by bike or public transport whenever possible.

Looking Forward to 2025
At GenDx, we are constantly looking for ways to improve and reduce our environmental footprint. Whether it’s through big company-wide changes or individual habits, we’re committed to making a positive impact.

The GenDx Sustainability team

NGSgo®-ProntoAmp now compatible with Illumina!

We are excited to announce that NGSgo®-ProntoAmp, our latest HLA amplification solution, is now compatible with Illumina sequencing platforms!

Initially launched for ONT platforms in September, this product has taken a step forward and is now fully compatible with Illumina sequencing systems!

How does it work?
Simply amplify your DNA with NGSgo-ProntoAmp and continue library preparation with the NGSgo® Library Full Kit. Sequence your library as usual on your Illumina system.

Benefits:
-Premixed primers and enzyme, just add DNA
-Fast PCR protocol (90 min)
-Improved signal to noise
-11 HLA loci (3-tube multiplex)

Interested? Check our product pages:
https://www.gendx.com/product_line/ngs-pronto/
https://www.gendx.com/product_line/ngsgo-library-full-kit/

Rebrand to reflect growth, innovation, and a unified vision

Utrecht, 11 November 2024

We are happy to announce that GenDx will undertake a brand update to align with the evolving structure of the Eurobio Scientific Group.

This new brand embodies the collective strengths of all our affiliates, combining expertise and resources to create synergies to enhance our product offerings. Furthermore, our collaboration will allow us to drive innovation through sharing knowledge, ensuring that we deliver innovative products and services that are at the forefront of the diagnostics field. And while our brand is evolving, our commitment to do so remains our top priority.

Denis Fortier, CEO & Chairman of Eurobio Scientifics Executive Committee, states: “This rebranding reflects who we are, our evolution as a larger group, representing growth, innovation, and a unified vision to become a leading global Specialty Diagnostics company offering highly innovative solutions. Our mission remains the same: Lead breakthrough innovation in the fields of infectious diseases, transplantation & oncology by developing and supporting a comprehensive portfolio of molecular diagnostics technologies encompassing our own solutions and those of our partners. ”

Why is the brand changing?

We are transitioning to a new brand identity that reflects the integration of all affiliates within the Eurobio Scientific Group. This means our visual identity will be updated to ensure consistency and foster harmony among the group’s companies.

What is changing?

We will have a new brand that reflects consistency across the Eurobio group companies, this means an update to our logo, icon, typography, form elements and color scheme.

Logo: We now have a logo that is part of a cohesive logo family while maintaining similar color schemes to what it is familiar to us. The GenDx logo consists of two parts: “Eurobio’’ as the main family name, followed by the name of the family member “GenDx’’.

Icon: All company divisions now share a distinctive brand icon, which serves as a unifying element for the Eurobio Group’s identity. Each affiliate uses the icon with their own color palettes.

Product packaging, labels, and documentation: We will gradually update all product packaging, labels, and documents to align with the new branding. During this transition, you may encounter both the old and new branding until all materials are fully updated. Please note that the content itself will remain unchanged.

Products & Services: There will be no changes to our products and services. Our dedicated team, high-quality products, and services will remain the same.

Sustainable rebranding

The rebranding process will unfold over the coming months, focusing on minimizing waste. By reusing materials such as product boxes, brochures, and exhibition booths, we aim to ensure an environmentally friendly transition. As a result, you may still see our old branding during the transition period.

Thoughts from leadership:

“What I like a lot about the branding is that it unifies the group, but it also gives every company their unique color.’’ Hanneke Merkens, Eurobio Chief Marketing Officer says “So the Eurobio as a group is blue and GenDx remains purple. DID is red, TECOmedical and BMD have their own shade of blue. That’s what I like a lot because it gives every individual affiliate their own identity and still keeps as a part of the group. We share the same font, the same logo, and we also share the same icon. And especially the icon is a nice visual, created to make sure that everyone recognizes us as Eurobio Group while we keep our own identity.’’

“I see an exciting future for Eurobio Scientific as a group.’’ Maarten Penning, GenDx General Manager, and Eurobio Chief Technology Officer added “We have combined our strengths in research and development, software development, marketing, customer support, sales, and all associated service and support, efforts. So in this new constellation, I am confident that we can keep on developing new innovative products that will be of benefit to patients worldwide, that we can grow as a company and develop multiple innovative diagnostic solutions.”

We look forward to embarking on this new phase of our visual identity together with you and strengthening our commitment to advancing the field of transplantation.

High-Resolution Nanopore sequencing for 4-96 samples per run

We’re excited to share that NGS-Pronto® is now available! Designed for Oxford Nanopore Technologies sequencing devices, NGS-Pronto® offers multiplex amplification of 11 loci and library preparation reagents, complete with 96 barcodes, providing a fast, easy and efficient workflow.

Workflow made simple
NGSgo-ProntoAmp offers amplification of 11 HLA loci using a whole-gene approach, resulting in at least a 3-field resolution.

NGS-ProntoPrep offers a complete barcoded library preparation for sequencing on Oxford Nanopore Technologies sequencing devices. The library preparation only takes 1.5-2 hours and is suitable for 4 to 96 samples. Since there is no fragmentation, long intact amplicons are generated, enabling full phasing.

Turnaround time from DNA to results for 12 samples:

You can find out more about NGS-Pronto by visiting the product page.

NGSgo-ProntoAmp and NGS-ProntoPrep are now available as RUO

Ready to start using NGS-Pronto?

Order Now

Contact our Sales team

NGSengine 3.1 now available!

NGSengine®, our software for NGS-based HLA analysis, was developed in 2012 and has since undergone major developments, including the recent release of NGSengine 3.1. NGSengine®3 customer feedback has been the driving force behind our continuous commitment to enhancing our software. Throughout the years, we have consistently elevated the standards for optimal result visualization and dedicated efforts to refining our algorithms, ensuring that we deliver reliable typing results.

We are proud to announce the changes we have made and we trust that they will further enhance your experience with NGSengine®3! Among the key improvements in NGSengine 3.1. you can find:

• New phasing algorithm
• Improved insertion detection and reporting
• Improved ignore region management
• New options to display ambiguities in the genotype ranking view
• Extended analysis region for DPB1
• Improved user experience

Update now
Make sure to update your software to the latest version of NGSengine®3. For a complete overview of the improvements, other changes, and bugfixes, please check the release certificate. You can also find the latest instruction for use documents for NGSengine here. NGSengine®3 continues to deliver the results you rely on.

Download NGSengine 3.1

Download release certificate – NGSengine 3.1

Download release certificate – NGSignition 3.1

PRESS RELEASE

Utrecht, 21 November 2023

During the opening of their new offices GenDx Announces a Collaboration Agreement with OSE Immunotherapeutics for the Development of the NGSgo® HLA-A typing kit and NGSengine® software as a Companion Diagnostic for an Epitope-Based Cancer Vaccine.

GenDx, a Eurobio Scientific Company, today announced that the Company has entered into a collaboration with OSE Immunotherapeutics (a French biotech company dedicated to developing first-in-class assets in immuno-oncology) to develop and validate a companion diagnostic (CDx) test for high resolution typing of HLA-A*02 based on their IVDR registered NGSgo® kit and NGSengine® software. This test will support the confirmatory pivotal Phase 3 clinical trial of Tedopi® cancer vaccine in preparation in Non-Small Cell Lung Cancer (NSCLC) second line treatment.
Under the Master Collaboration Agreement, GenDx will develop and validate a companion diagnostic test for a predictive immunological biomarker to identify patients with HLA-A*02 genotype who are biological responders to Tedopi® epitopes. The CDx test, based Next-Generation Sequencing (NGS) technology, will support the enrolment of eligible NSCLC patient in the upcoming registration pivotal Phase 3 of Tedopi®. The objective of this study will be to confirm the efficacy and safety of Tedopi® in second line treatment post-immune checkpoint inhibitor (ICI) failure in HLA-A*02 positive NSCLC patients to support Tedopi®’s registration in both United States and Europe.
This first announcement of GenDx’ step towards the companion diagnostic market falls together with the opening of their new offices located at the Utrecht Science Park. As the new location provides an expansion of the offices, production, and R&D facilities, GenDx can now can keep on supporting the growing demand of customers globally for innovative products for transplant diagnostics. The new office reflects GenDx’ commitment to foster innovation and collaboration within the transplant community. It will also serve as a center for hosting training courses and it houses a new studio to provide online education to the HLA-typing community.

Maarten Penning, General Manager of GenDx, says:
“In this project, our regulatory expertise, illustrated by being one of the first IVDR compliant companies, and our extensive knowledge of developing software and reagents for accurate high resolution HLA typing using NGS, come together in the development of a companion diagnostic assay for HLA-A*02. We are very happy to enter in this strategic collaboration with OSE, as we aim to contribute to improve the quality of life and survival of patients.”

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments:
“Through this strategic collaboration, we are very pleased to be working with GenDx, the leading high-resolution HLA typing company. This companion diagnostic test will be useful for selecting HLA-A*02 eligible cancer patients and thus accelerating the clinical development and regulatory registration of Tedopi® as a precision medicine innovative treatment”

About HLA
The Human Leukocyte Antigen (HLA) system comprises a diverse family of genes and allelic variants crucial for the human immune system. Precise HLA matching between patients and donors is essential in transplantation, as even slight differences in HLA alleles can significantly impact transplant outcomes. HLA typing enables the identification of specific nucleotide sequences, making it an indispensable tool for transplantation purposes.

About GenDx, a Eurobio Scientific Company
Genome Diagnostics B.V., trading as GenDx, is a Dutch company specializing in molecular diagnostics. It focuses on the development, production, and sale of innovative assays and analysis software for transplantation and companion diagnostics. GenDx offers a range of HLA sequencing-based typing strategies, reagents, software, and custom laboratory services. GenDx Education also provides dedicated training courses worldwide for professionals in tissue typing, research laboratories, blood banks, and donor registries. In
October 2022, Eurobio Scientific acquired all shares of GenDx. For more information, visit www.GenDx.com.

About Eurobio Scientific
Eurobio Scientific is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 290 employees and four production units based in France in the Paris region, in Germany, in the Netherlands and in the United States, and several affiliates based in Dorking UK,
Sissach Switzerland, Bünde Germany, Antwerp Belgium, Milan in Italy and Utrecht in the Netherlands. Eurobio Scientific’s reference shareholder is the EurobioNext holding company which brings together its two directors, Jean-Michel Carle and Denis Fortier, alongside the “Pépites et Territoires” by AXA & NextStage AM investment program, managed by NextStage AM. For more information, please visit : www.eurobio-scientific.com The company is publicly listed on the Euronext Growth market in Paris Euronext Growth BPI Innovation, PEA-PME
150 and Next Biotech indices, Euronext European Rising Tech label. Symbol: ALERS – ISIN Code: FR0013240934 – Reuters: ALERS.PA – Bloomberg: ALERS:FP

About OSE Immunotherapeutics
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation. The Company’s current portfolio is well-balanced first-in-class clinical pipeline including Tedopi®, OSE-279 (anti-PD1), OSE-127 (lusvertikimab), FR-104/VEL-101 (anti-CD28 monoclonal antibody) developed in partnership with Veloxis Pharmaceuticals, Inc., BI 765063 and BI 770371 (anti-SIRPα monoclonal antibody) developed in partnership with Boehringer Ingelheim. OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: BiCKI® platform focused on immunooncology (IO) and the Myeloid platform focused on optimizing the therapeutic potential of myeloid cells in IO and immuno-inflammation (I&I). Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com

GenDx
Yalelaan 48
3584 CM Utrecht
The Netherlands
Office: +31 30 252 3799
E-mail: info@gendx.com

Contact GenDx: Hanneke Merkens PhD, Chief Marketing Officer GenDx , Email: h.merkens@gendx.com , Phone: +31 612655845
NGSgo® , NGSengine® and GenDx are registered trademarks of Genome Diagnostics B.V.

Contact OSE Immunotherapeutics: Nicolas Poirier, Chief Executive Officer, nicolas.poirier@ose-immuno.com

GenDx proudly presents NGSengine-Turbo version 1.0.0, the NGS-Based HLA typing software designed to streamline the analysis of data generated with our NGS-Turbo assays. NGSengine-Turbo introduces a range of powerful features that will greatly improve the way you approach fast HLA typing.

Key Features of NGSengine-Turbo:

1. Regular Updates Included: With at least two updates per year, NGSengine-Turbo ensures that you’re equipped with the latest databases. This means you can focus on your research, confident that your software is always up-to-date.
2. Intuitive Interface: Simplicity and efficiency are paramount in your work. NGSengine-Turbo’s intuitive interface ensures that you can navigate through the software with ease.
3. Built on the Renowned NGSengine Software: NGSengine-Turbo is built upon the solid foundation of the renowned NGSengine software. This robust platform has been meticulously fine-tuned to optimize data analysis for ONT data, ensuring the highest level of precision and reliability. Trust in your HLA typing results with NGSengine-Turbo.

A Closer Look:

After the sequencing process, NGSengine-Turbo provides rapid data analysis within minutes. The software’s advanced algorithms, developed based on the tried-and-true NGSengine, guarantee exceptional accuracy and performance, specifically tailored for ONT data.

The reporting process is straightforward and user-centric, delivering precisely the information you need to effectively communicate your typing results.

NGSengine-Turbo is now available as a Research Use Only (RUO).

Interested?

Interested to try out NGSengine-Turbo 1.0.0?

Contact now our Support Team to request a trial licence!

PRESS RELEASE

Utrecht, 17 October 2023

GenDx launches NGS-Turbo®: revolutionizing high-resolution HLA typing with Oxford Nanopore Technologies sequencing devices

GenDx, a Eurobio Scientific Company, has announced the launch of their newly developed product, NGS-Turbo, designed for HLA typing using Oxford Nanopore Technologies sequencing devices. NGS-Turbo represents a significant leap forward in the field of HLA typing, offering unparalleled speed and efficiency when time is of the essence.
With the release of this new product, GenDx continues to push the boundaries of innovation in the field of HLA typing, and NGS-Turbo demonstrates their commitment to providing cutting-edge solutions for the transplantation community.
NGS-Turbo is characterized by its exceptional turnaround time, providing high-resolution HLA typing results in as little as three hours, from blood sample to the final result. The innovative product is composed of two essential workflow components: NGS-TurboAmp and NGS-TurboPrep.
NGS-TurboAmp facilitates rapid amplification, completing the process in a mere 90 minutes, targeting 11 HLA loci using a whole-gene approach.
NGS-TurboPrep offers a library preparation designed specifically for Oxford Nanopore sequencing devices. In just 30 minutes, users can perform library preparation in a single well with little effort, thanks to pre-filled color-coded reagents. The preparation process eliminates the need for fragmentation, can be conducted at room temperature, and offers the flexibility to pause if necessary.
The sequencing step, performed on an Oxford Nanopore device, takes as little as 20 minutes to generate high-quality data, ensuring precise and accurate typing results.

Maarten Penning, PhD, General Manager of GenDx, expressed his excitement about the product’s launch, stating, “We are continuously evolving our HLA typing product lines to meet the dynamic demands of the field. Our collaboration with Oxford Nanopore has led to the development of an assay that not only seamlessly integrates with their platform but also excels in speed and user-friendliness. The overwhelmingly positive feedback received during the early access program speaks volumes about the product’s potential impact. NGS-Turbo will be a transformative solution for laboratories seeking high-resolution HLA typing with rapid turnaround times.”
For more information about NGS-Turbo and GenDx’s comprehensive range of HLA typing solutions, please visit www.gendx.com.

About HLA

The Human Leukocyte Antigen (HLA) system comprises a diverse family of genes and allelic variants crucial for the human immune system. Precise HLA matching between patients and donors is essential in transplantation, as even slight differences in HLA alleles can significantly impact transplant outcomes. HLA typing enables the identification of specific nucleotide sequences, making it an indispensable tool for transplantation purposes.

About Oxford Nanopore Technologies

Oxford Nanopore Technologies’ goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for real-time, high-performance, accessible and scalable analysis of DNA and RNA. The technology is used in more than 120 countries to understand the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses and whole environments. Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes.

About GenDx, a Eurobio Scientific Company

Genome Diagnostics B.V., trading as GenDx, is a Dutch company specializing in molecular diagnostics. It focuses on the development, production, and sale of innovative assays and analysis software for transplantation and companion diagnostics. GenDx offers a range of HLA sequencing-based typing strategies, reagents, software, and custom laboratory services. GenDx Education also provides dedicated training courses worldwide for professionals in tissue typing, research laboratories, blood banks, and donor registries. In October 2022, Eurobio Scientific acquired all shares of GenDx. For more information, visit www.GenDx.com.

About Eurobio Scientific

Eurobio Scientific is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 170 employees and three production units based in France, in the Paris region, in Germany and in the United States, and several affiliates based in Dorking UK, Sissach Switzerland, Bünde Germany and Utrecht in The Netherlands. Eurobio Scientific’s reference shareholder is the EurobioNext holding company which brings together its two directors, Jean-Michel Carle and Denis Fortier, alongside the “Pépites et Territoires” by AXA & NextStage AM investment program, managed by NextStage AM. For more information, please visit : www.eurobio-scientific.com The company is publicly listed on the Euronext Growth market in Paris Euronext Growth BPI Innovation, PEA-PME 150 and Next Biotech indices, Euronext European Rising Tech label. Symbol: ALERS – ISIN Code: FR0013240934 – Reuters: ALERS.PA – Bloomberg: ALERS:FP

GenDx Yalelaan 48, 3584 CM Utrecht, The Netherlands, Office: +31 30 252 3799, E-mail: info@gendx.com

Contact GenDx: Hanneke Merkens PhD, Director Marketing and Communication Email: m.merkens@gendx.com, Phone: +31 6 12 65 5845

Download the full press release here

Read more about NGS-Turbo here

We are happy to announce that GenDx is supporting ASHI 2023 with a platinum sponsorship! The conference will be held this year from Monday, October 16, to Friday, October 20.
Make sure to join us in our activities!

Teaching Session (on site training)

Monday, October 16, 2023, 9:00 AM – 4:30 PM PDT | San Antonio Marriott Rivercenter

This year’s training will have 2 sesions. The morning session will focus on advanced data analysis and case studies using our NGSengine software. The afternoon session will focus on new sequencing technologies for HLA typing, including our new NGS-Turbo workflow and data analysis. NGS-Turbo is a High Resolution typing assay using Oxford Nanopore sequencing.

More information and registration here

GenDx User Group Meeting

Tuesday, October 17, 12:15 pm – 02:05 pm | San Antonio Marriott Rivercenter

User’s Perspective on New Technologies: Improving HLA Typing workflows using Nanopore & Chimerism Monitoring with NGS

12:15pm Welcome & Introduction, Maarten Penning PhD, CTO & General Manager at GenDx
12:30pm User’s Perspective: Real Time PCR & Nanopore Sequencing Comparison, Alison J. Gareau, PhD, D(ABHI)
1:00pm User’s Perspective: Post Transplant Monitoring with STR & NGS , Valia Bravo-Egana, PhD, F(ACHI), MBA
1:30pm GenDx New Developments, Hanneke Merkens PhD, CMO at GenDx
2:00pm Wrap-up Final Questions, Maarten Penning PhD, General Manager at GenDx

Tulip Run

Wednesday, October 18, 6:30 am – 8:00 am | San Antonio Convention Center

Join us on this morning run, sponsored by GenDx, and contribute to a common goal: enhancing the outcome of transplantation. All runners and walkers are welcome. Don’t forget to add the run to your meeting registration!

More information on the ASHI Tulip Run can be found here. Find photos from previous Tulip Run events here

Posters 

Our poster will be available online on the ASHI platform and in person during the meeting.

• • HLA loss detection by NGS using a multiplex of 16 markers within the MHC region

Job Geerligs, Lisa Rond, Fereshte Dadkhodaie, Loes van de Pasch, Maarten Penning, Sake van Wageningen

For more information and registration at ASHI, visit https://www.ashi-hla.org/

Looking forward to seeing you there!

PRESS RELEASE

Utrecht, 29 June 2023

The board of GenDx announces that Maarten Penning, PhD, will assume the helm of the company and is appointed General Manager, as Wietse Mulder PhD will step down as CEO per July, 1^st 2023. Per the same date, Maarten Penning PhD will also become executive director of the GenDx Board, joining directors, Denis Fortier and Hervé Duchesne de Lamotte, representing Eurobio Scientific, GenDx’s parent company.

Maarten Penning is trained as a molecular biologist and joined GenDx for more than 13 years. He has executed various roles at the company ranging from project management, business development till his current job as CTO where he oversees the global R&D of Eurobio Scientific group. As deputy CEO, he also chaperoned the GenDx leadership team for several years. Maarten Penning is a trusted and respected person in the field and will provide its expertise to support the successful transition to a new era for GenDx, part of the Eurobio Scientific group.

At the same time, the Board announces that Wietse Mulder will continue to support GenDx as Ambassador. In that role he will support the GenDx Leadership Team (members) and will devote a particular attention to marketing and communication, including GenDx’s corporate social responsibility activities. He will also continue to actively represent GenDx, locally, and at international conferences.

Since January 2004, Wietse Mulder has devoted full attention to the GenDx project. From a draft business plan and establishing the company in 2005, developing new products, till today where GenDx has become a well-respected company in the field of transplant diagnostics and intends to become a major player in the market through its combination with Eurobio. Thus, the company is at a milestone while it’s entering the field of companion diagnostics and cfDNA diagnostics.

Wietse Mulder comments: “Leaving executive office of GenDx is a major step in the pursue of my career as Life Science entrepreneur. I am proud that together with Erik Rozemuller and all GenDx colleagues, we have achieved a lot for the transplantation diagnostics market. I enjoyed having worked for almost 20 years at GenDx in a truly collaborative atmosphere. Following last year’s transaction, I feel that we found with Eurobio Scientific the best home to ensure continuity with our partners and clients, and the entrepreneurial spirit needed to further develop GenDx.

I am proud to see that we have maintained the same spirit since we started. Focused on educating workers in the transplant field, enabling better HLA typing, allowing better matching and together with accurate transplant monitoring, increasing the success of solid organ and stem cell transplantation. As an ambassador, I will continue to support GendX with the same commitment/dedication”

Maarten Penning comments: “It is an honor to be the successor of Wietse Mulder, after working together since 2010. It’s impossible to fully express what Wietse Mulder does mean for GenDx and colleagues. I am looking forward to continue to support and educate our partners in the transplant diagnostic field. I am motivated to make GenDx even more successful in the coming years, together with the GenDx Leadership Team and all other fantastic GenDx colleagues. Based on the GenDx experiences, I am confident that together we will also have a meaningful contribution to the success of EuroBio Scientific Group. “

About GenDx, a Eurobio Scientific Company

Genome Diagnostics B.V., also known as GenDx, is a Dutch company specialized in molecular diagnostics, focused on development, production and sales of innovative assays and analysis software for transplantation and companion diagnostics. To support GenDx’s USA customers it has an office near O’Hare airport, Chicago, IL. GenDx specializes in (Sanger and NGS) HLA sequencing-based typing strategies and offers both reagents and software. As one of the sequencing pioneering companies in the HLA field, GenDx started offering NGS strategies in 2013, consisting of NGSgo® reagents and the software package NGSengine® for various NGS platforms. Additionally, GenDx offers products for chimerism monitoring by qPCR and – launched recently – by NGS: NGStrack® & TRKengine®. Thanks to its extensive in-house expertise, GenDx also offers custom laboratory services for basic and clinical research organizations. GenDx Education organizes dedicated HLA sequence-based typing and chimerism monitoring training courses worldwide on a regular basis for anyone working in tissue typing or research laboratories, blood banks, and donor registries. GenDx is based in the Alexander Numan building at the Utrecht Science Park, the Netherlands and was founded in 2005 by Erik Rozemuller PhD, Wietse Mulder PhD. In October 2022, Eurobio Scientific acquired all shares of GenDx. For further information about GenDx visit www.GenDx.com.

About Eurobio Scientific

Eurobio Scientific is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 180 employees and three production units based in France, in the Paris region, in Germany and in the United States, and several affiliates based in Dorking UK, Sissach Switzerland, Bünde Germany and Utrecht in The Netherlands. Eurobio Scientific’s reference shareholder is the EurobioNext holding company which brings together its two directors, Jean-Michel Carle and Denis Fortier, alongside the “Pépites et Territoires” by AXA & NextStage AM investment program, managed by NextStage AM. For more information, please visit : www.eurobio-scientific.com The company is publicly listed on the Euronext Growth market in Paris Euronext Growth BPI Innovation, PEA-PME 150 and Next Biotech indices, Euronext European Rising Tech label. Symbol: ALERS – ISIN Code: FR0013240934 – Reuters: ALERS.PA – Bloomberg: ALERS:FP

GenDx Yalelaan 48, 3584 CM Utrecht, The Netherlands, Office: +31 30 252 3799, E-mail: info@gendx.com

Contact GenDx: Hanneke Merkens PhD, Director Marketing and Communication Email: m.merkens@gendx.com, Phone: +31 6 12 65 5845

Download the full press release here

PRESS RELEASE

Utrecht, May 25, 2023

GenDx has obtained a worldwide license from Università degli Studi di Torino (UNITO) for their method to detect donor specific cell free DNA (cfDNA) in patients that have undergone a lung transplant.
To monitor graft survival, patients typically need bronchoscopy or lung biopsies that are invasive, require anaesthesia and are risky. Moreover, these methods suffer from interobserver variability and are expensive. Researchers at UNITO developed a method that instead requires only a blood sample to monitor transplant rejection. The method comprises a sensitive digital droplet PCR assessment of the cfDNA donor fraction and is superior to biopsies in terms of costs, turnaround time and level of sensitivity. The assay, although developed for lung transplant patients, opens a door for broader solid organ transplants as it supports a pan-organ strategy.
This UNITO license broadens the licence agreement that was obtained earlier from Medical College Wisconsin for its method to detect cfDNA in paediatric patients that have undergone a heart transplant.

Wietse Mulder PhD, CEO of GenDx, commented: “Combining the knowledge of both UNITO on cfDNA and GenDx on DNA typing by NGS and real-time PCR in a transplant setting, offers an enormous potential to develop products which can predict early the potential rejection of transplanted organs. We are excited to collaborate with UNITO enabling new options for accurate transplant monitoring”

Statement UNITO, said: “We are glad to start this new collaboration with GenDx and excited to see that a research idea from our group can move forward and hopefully become a kit. Our goal now is to go on with the necessary steps to optimize our method to fit it in a box and validate it in larger cohorts of patients, working in close collaboration with a company that is a leader in the field of molecular diagnostics for transplantation.”

About Cell free DNA
Donor derived cfDNA refers to all non-encapsulated DNA fragments that enter the bloodstream; this mostly happens during apoptosis or necrosis. Analysis of cell free DNA (cfDNA) after solid organ transplantation has been shown to accurately identify and characterize allograft injury and correlate with pathologic findings (e.g. organ rejection).

About the UNITO
The University of Torino (UniTo) in north-west Italy is one of the country’s largest and most prestigious universities. Founded in 1404, UniTo provides quality higher education and research opportunities; many UniTo graduates have achieved international renown. Today, the University of Torino offers over 150 undergraduate and graduate degree programs in almost every field of study. A growing number of programs are taught in English, and Italian language tuition is available for incoming students. The University’s 27 departments offer excellent opportunities for Italian and non-Italian academic staff; doctoral school provides more than 30 doctoral programs.

About Eurobio Scientific
Eurobio Scientific is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 148 employees and three production units based in France, in the Paris region, in Germany and in the United States, and several affiliates based in Dorking UK, Sissach Switzerland, Bünde Germany and Utrecht in The Netherlands.

Download the full press release here

The Tulip Run during the annual EFI meeting in Nantes was a big success! More than 50 participants joined us as we ran 5k through the stunning Parc du CRAPA de l’Ile Beaulieu.

€1400 was raised from registrations and donations and GenDx doubled the amount, offering ultimately €2800 to ADOT, the French federation for the donation of organs and human tissues. We would like to express our deepest appreciation to all the participants who ran alongside us and contributed to this cause. It’s inspiring to see people come together for a common goal and make a difference in the world!

For those who couldn’t make it, we invite you to visit our Tulip Run Gallery on our website to view some of the amazing pictures from the event.

Thank you for your support, and we look forward to seeing you in our future events!

Until next year at the EFI 2023 in Jerusalem!

GenDx is proud to participate in METHYLOMIC, a study funded by the European Union. The project is aiming to enhance the effectiveness of medication in chronic immune-mediated diseases such as Crohn’s Disease (CD), Rheumatoid Arthritis (RA), and Psoriasis (PsO).

As experts in developing personalized diagnostic assays and software, GenDx partnered with Amsterdam UMC in 2017, in various precursors of the METHYLOMIC project. In this collaboration, we bring together scientific expertise with commercial and regulatory proficiency, facilitating the translation of scientific findings regarding differential methylation profiles in Crohn’s into a reliable, fast, affordable and user-friendly test for clinical diagnostics.

Participation in the METHYLOMIC project allows GenDx to establish all required collaborations that will help create an innovative assay. This allows the consortium to develop a solution that benefits all stakeholders, but most importantly makes life better for patients suffering from Crohn’s disease.

To learn more about the project, visit the recently launched website at https://methylomic.eu.

NGStrack® & TRKengine®

Our NGStrack assay combines the use of NGS with highly sensitive indel markers to monitor chimerism. The latest design of the assay, released as of today, has 34 markers multiplexed in just 2 mixes. This setup allows for a DNA input of only 60 ng per sample. Ultimately, the results are visualized in just a few steps with our user-friendly and intuitive software, TRKengine.

The assay: NGStrack®

High-sensitivity chimerism monitoring
With NGStrack you can reach at least 0.5% sensitivity, which is 2-10 times more sensitive than STR assays. The kit features 34 markers multiplexed in 2 mixes for a fast workflow and excellent quality. After a single typing experiment on a pre-sample, all monitoring samples can be measured without the need to include the pre-sample again. The markers overlap with our qPCR KMR reagents, allowing parallel use of the two techniques. Additionally, NGStrack can be combined with NGSgo HLA samples on the same flow cell.

Benefits

✓ Reliable at all chimerism percentages
✓ 2-10 times more sensitive than STR
✓ Only 60 ng DNA needed per sample
✓ Short workflow, 75 min hands-on
✓ Test the pre-sample only once

The software: TRKengine®

Easy trend analysis
Assay results can easily be imported in our intuitive software, TRKengine. The analysis takes just a few minutes and the use of indels, detection is even possible below the sequencing noise levels. The user-friendly interface provides extensive options for donor/recipient management and allows for effortless trending over time.

Benefits
✓ Fast data analysis <5 min
✓ User-friendly overviews
✓ Trend and report chimerism over time
✓ Extensive database management
✓ Works on a standard PC or laptop

Ready to start chimerism monitoring by NGS?

NGStrack and TRKengine are now available for research use only (RUO). Contact us to ask for a demo or for additional information, we will be happy to answer your questions!

Order now!

Request a demo

The Tulip Run during the annual ASHI meeting in Las Vegas was a big success!

Together with more than 100 participants, we did the 5k run through the beautiful Sunset Park. $2925 was raised from registrations and donations and GenDx doubled the amount, offering ultimately $5850 to the Nevada Donor Network.

You can check the pictures of the event by visiting the Tulip Run Gallery on our website.

Until next year at the ASHI 2023 in San Antonio!

We are excited to share that GenDx received the new certification for our MDSAP-compliant quality system by our notified body TÜV SÜD. The scope of the certification entails the design, development, manufacture and distribution of In Vitro Diagnostic Medical Devices including software. Besides the regulatory requirements of Canada, our MDSAP quality system now also covers the Brazilian regulations.

The MDSAP certificate is a prerequisite to register our products as in-vitro diagnostic (IVD) device in Brazil.

PRESS RELEASE

Per today the Paris, France-based Eurobio Scientific (“Eurobio”) acquires all outstanding shares of GenDx (also known as Genome Diagnostics) as was publicly announced after signing the Share Purchase Agreement on 17 August.

ad tempus vitae

This transaction is the result of an intensive project called ad tempus vitae (“ATV”), meaning ‘to prolong life’. This term carries double meaning. Firstly, it refers to GenDx’s offering of products and services aimed at prolonging the life of transplant patients. Secondly, it refers to prolonging the life of the Company, GenDx, by securing the legacy of the founders , which has been built over the last 18 years. The GenDx ATV project was coordinated by Jason Arnold and his London-based M&A advisory team at William Blair, with legal support from Herke van Hulst, Wouter Kok and team at Osborne & Clarke in Amsterdam. RSM provided vendor financial due diligence services to the Company.

Fostered by the adagium of ‘meaningful entrepreneurship’, Mulder and Rozemuller will establish the ‘GenDx foundation’, funded by proceeds of this transaction, aiming at supporting educational and R&D activities in the field of transplantation.

About Eurobio Scientific

Eurobio Scientific is a key player in the field of specialty in vitro diagnostics. It is involved from research to manufacturing and commercialization of diagnostic tests in the fields of transplantation, immunology and infectious diseases, and sells instruments and products for

research laboratories, including biotechnology and pharmaceutical companies. Through many partnerships and a strong presence in hospitals, Eurobio Scientific has established its own distribution network and a portfolio of proprietary products in the molecular biology field. The Group has approximately 148 employees and three production units based in the Paris region, in Germany and in the United States, and several affiliates based in Dorking UK, Sissach Switzerland, Bünde Germany and Utrecht in The Netherlands.

Eurobio Scientific’s reference shareholder is the EurobioNext holding company which brings together its two directors, Jean-Michel Carle and Denis Fortier, alongside the “Pépites et Territoires” by AXA & NextStage AM investment program, managed by NextStage AM.

For more information, please visit : www.eurobio-scientific.com

The company is publicly listed on the Euronext Growth market in Paris

Euronext Growth BPI Innovation, PEA-PME 150 and Next Biotech indices, Euronext European Rising Tech label.

Symbol: ALERS – ISIN Code: FR0013240934 – Reuters: ALERS.PA – Bloomberg: ALERS:FP

About GenDx

Genome Diagnostics B.V., also known as GenDx, is a Dutch company specialized in molecular diagnostics, focused on development, production and sales of innovative assays and analysis software for transplant and companion diagnostics. To support GenDx’s USA customers it has an office near O’Hare airport, Chicago, IL.

GenDx specializes in HLA sequencing-based typing strategies and offers reagents and software for both Sanger and NGS approaches. As one of the pioneering companies in the HLA field with Sanger approaches, GenDx started offering NGS strategies in 2013, consisting of NGSgo® reagents and the software package NGSengine® for various NGS platforms. Additionally, GenDx offers products for chimerism monitoring by qPCR and – launched recently – by NGS: NGStrack® & TRKengine®.

Recently a license was obtained from California based company Dovetail Genomics (now part of Cantata Bio) allowing GenDx to explore their hybrid capture approach enabling HLA genotyping and ultimately haplotyping of HLA genes.

Furthermore, GenDx obtained another worldwide license from Medical College Wisconsin (MCW) for their patented method to detect donor specific cell free DNA (cfDNA) in pediatric patients that have undergone a heart transplant. And, last month GenDx has signed a non-exclusive service agreement with Oxford Nanopore Technologies (Oxford Nanopore), to bring its new NGS-Turbo® product to the transplant market for high-resolution HLA typing with a turnaround time of less than four hours, enabling improved matching of solid organs in situations where time is a critical factor.

Thanks to its extensive in-house expertise, GenDx also offers custom laboratory services for basic and clinical research organizations. GenDx Education organizes dedicated HLA sequence-based typing and chimerism monitoring training courses worldwide on a regular basis. The training courses are applicable for anyone working in tissue typing or research laboratories, blood banks, and donor registries.
GenDx is based at the Utrecht Science Park (USP), the Netherlands, and was founded in 2005 by Erik Rozemuller PhD and Wietse Mulder PhD as a spinoff of UMC Utrecht and helped by a 2002 Biopartner First Stage Grant. In 2019, Ampersand Capital Partners acquired a minority stake in the Company.
Currently, GenDx is located at USP in two opposite buildings: Alexander Numan and Androclus. In Q1-2023, GenDx will expand its footprint in A. Numan building by additionally leasing the top three floors of that building. The activities in Androclus will gradually be migrated to Numan building. Total facilities will encompass more than 3000 m2.
For further information about GenDx visit www.GenDx.com.

Download the full press release here

Download press release of Eurobio Scientific here

UPDATE

The results of this year’s stem cell donor recruitment day are in! 129 people registered using our event code, meaning that GenDx donates €4.515, to Matchis.

A big thank you to everyone who contributed to this year’s edition. Whether you helped with promoting the event, helped spreading awareness on the topic, or volunteered during the event. Together, we reached our goal, which was to motivate as many young, healthy people as possible to join the stem cell donor registry.

We look forward to continuing our collaboration with the Matchis foundation next year. In 2023, the event will again take place in the week of the world marrow donor day.

In the week preceding the World Marrow Donor Day, GenDx is organizing an annual Stem Cell Donor Recruitment Day. This initiative is established in cooperation with Matchis, the Dutch center for stem cell donors, and in line with GenDx’s mission to improve the quality of life and survival of transplant patients. Our main aim is to motivate as many young, fit people to register as a potential stem cell donor.

This year, the event takes place on Thursday 15 September 2022 at various locations, mainly at Utrecht Science Park, but also in Leiden (LUMC).

Do you want to make a difference for a patient who needs a stem cell transplant to get a chance to live?  Join the stem cell donor registry! 

If you register using our event code ‘GENDX22’, GenDx will support the Matchis Foundation financially by covering the costs they make for processing your registration, i.e. 35 euros. The code is valid from 12 – 23 September, surrounding our annual Stem Cell Donor Recruitment Day.

Read more about it here: Stem Cell Donation

September 13 we will have special webinars to raise awareness on the topic. Click here to register

We are happy to announce that GenDx is supporting ASHI 2022 with a platinum sponsorship! The conference will be held this year from Monday, October 24 to Friday, October 28.
Make sure to join us in our activities!

Teaching Session

Monday, October 24, 2022, 10:00 AM – 5:00 PM PDT | Las Vegas

Join our training and become an expert in HLA typing. This course will focus on HLA typing by NGS and is aimed for both beginners and advanced users.

More information and registration here

Tulip Run

Wednesday, October 26, 6:30 am – 7:30 am | Sunset Park, Las Vegas, NV

Walk or run to this event, sponsored by GenDx, and join us on the common goal: enhancing the outcome of transplantation. Proceeds from this event will benefit a local OPO in Las Vegas, Nevada. All runners and walkers are welcome. Don’t forget to add the run to your meeting registration!

More info about the event here.

Find photos from previous Tulip Run events here

User Group Meeting: Why Gamble on your Rapid HLA Typing or Chimerism Testing?  Hit the Jackpot with GenDx

Wednesday, October 26, 11:45 pm – 13:35 pm | 

Speakers:

• Pascal van der Weele PhD, Project Manager R&D at GenDx
• Erik Rozemuller PhD, Senior Scientist Bioinformatics at GenDx
• Maarten Penning PhD, Chief Technology Officer at GenDx

Posters 

Our posters will be available online on the ASHI platform.

• Rapid, robust and reliable high resolution HLA typing of 11 HLA loci using ont minion sequencing (Pascal van der Weele et al)
• Optimizing gene coverage for HLA class II gene sequencing (Sake van Wageningen et al)
• Direct vs indirect indexing for NGSBased Chimerism Monitoring (Maaike Rijkers et al)

Looking forward to meeting you!
For more information and registration at ASHI, visit https://www.ashi-hla.org/

PRESS RELEASE

NGS-Turbo® is a novel rapid high-resolution HLA typing kit aimed at improving transplant outcomes

GenDx today announces that it has signed a non-exclusive service agreement with Oxford Nanopore Technologies (Oxford Nanopore), to bring its new NGS-Turbo® product to the transplant market for high-resolution HLA typing with a turnaround time of less than four hours, enabling improved matching of solid organs in situations where time is a critical factor.
Organ transplantation requires a solid donor organ to be matched to a recipient. Due to time constraints, HLA typing of solid organs such as kidneys is typically restricted to low-resolution results. Nanopore technology allows for high-resolution sequencing in a time period that is suitable for critical organ transplantations. The agreement between GenDx and Oxford Nanopore lifts the 48-hour data processing restriction for commercial software, allowing NGS-Turbo® users to deliver high-resolution HLA typing results to the clinic within four hours after receiving the sample. This contributes to better organ matching and facilitates a better transplantation outcome.

Wietse Mulder PhD, CEO of GenDx, commented: “We are happy that we were able to come to an agreement with Oxford Nanopore. By combining our expertise as a world leader in sequencing-based HLA typing with the sequencing knowledge of Oxford Nanopore, we are convinced that we will be able to bring products to the organ transplantation field that allow better HLA typing, enabling better matching and improved outcome of transplantation.”

About NGS-Turbo®
NGS-Turbo® is one of the latest developments by GenDx. An early access program will start later this year. It consists of a fast amplification of all 11 HLA loci using a whole-gene approach with NGS-Turbo®Amp. After the subsequent extremely quick library preparation NGS-Turbo®Prep, a sample can be sequenced on Oxford Nanopore sequencers and the data can be directly analyzed and typed with NGSengine®. NGS-Turbo is an expansion of GenDx’ current high-resolution HLA typing portfolio.

About Oxford Nanopore Technologies
Oxford Nanopore Technologies’ goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for real-time, high-performance, accessible and scalable analysis of DNA and RNA. The technology is used in more than 120 countries to understand the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses and whole environments. Oxford Nanopore Technologies products are intended for molecular biology applications and are not intended for diagnostic purposes.

Read the full press release here

Read Full Press Release here: 2022 08 Press release GenDx-Eurobio Scientific

Training Course – Become an expert in NGS HLA typing

Are you interested in learning about high-resolution HLA typing or expanding your laboratory and data analysis skills? Then our course “Become an expert in NGS HLA typing” is for you! It will take place at the GenDx Headquarters in Utrecht, the Netherlands, in September and includes hands-on laboratory work of the complete NGS HLA workflow and data analysis.

The course includes:

• Theoretical knowledge of NGS for HLA
• Hands-on training of multiplexed NGS HLA typing
• Demonstrating multiple NGS platforms
• Training on data analysis with NGSengine® through case studies
• Send your own genomic DNA samples for typing (anonymized samples and data only)

ACHI accredited (1.5 CECs)
Participation fee*: 2.495 EUR (incl VAT)

Register now!

For this training course there are limited spots so make sure to register on time!

After registration, you will receive more information to prepare for the course.

*The tuition fee includes 3 hotel nights, drinks, refreshments, lunches, two dinners and all course materials. Travel costs to and from the location are not included and will be at the expense of the participant. 

PRESS RELEASE

GenDx has obtained a worldwide license from Medical College Wisconsin (MCW) for their patented method to detect donor specific cell free DNA (cfDNA) in pediatric patients that have undergone a heart transplant.

To monitor graft survival, patients need multiple endomyocardial biopsies that are expensive, require anesthesia and are invasive and risky. Researchers at MCW developed a method that instead requires only a small blood sample to monitor transplant rejection. The method comprises a sensitive multiplexed qPCR assessment of the cfDNA donor fraction, which is superior in terms of costs, turn-around time and level of sensitivity. The assay, although developed for pediatric transplant patients, opens a door for broader solid organ transplants as it supports a pan-organ strategy.

Wietse Mulder PhD, CEO of GenDx, commented: “Combining the knowledge of both MCW on cfDNA and GenDx on DNA typing by NGS and real-time PCR in a transplant setting, offers an enormous potential to develop products which can predict early the potential rejection of transplanted organs. We are excited to collaborate with MCW enabling new options for accurate transplant monitoring,”

About Cell free DNA

Donor derived cfDNA refers to all non-encapsulated DNA fragments that enter the bloodstream; this mostly happens during apoptosis or necrosis. Analysis of cell free DNA (cfDNA) after solid organ transplantation has been shown to accurately identify and characterize allograft injury and correlate with pathologic findings (e.g. organ rejection).

About the Medical College of Wisconsin

With a history dating back to 1893, The Medical College of Wisconsin is dedicated to leadership and excellence in education, patient care, research and community engagement. More than 1,500 students are enrolled in MCW’s medical school and graduate school programs in Milwaukee, Green Bay, and Central Wisconsin. MCW’s School of Pharmacy graduated its inaugural PharmD class in 2020. A major national research center, MCW is the largest research institution in the Milwaukee metro area and second largest in Wisconsin. In the last 10 years, faculty received more than $1.5 billion in external support for research, teaching, training and related purposes. This total includes highly competitive research and training awards from the National Institutes of Health (NIH). Annually, MCW faculty direct or collaborate on more than 3,100 research studies, including clinical trials. Additionally, more than 1,650 physicians provide care in virtually every specialty of medicine for more than 2.8 million patients annually.

References

Relationship between donor fraction cell-free DNA and clinical rejection in heart transplantation. Deshpande SR, et al. Pediatr Transplant. 2022. PMID: 35258162

Read the press release in genomeweb

Read the full press release here

GenDx obtains a license for haplotyping within transplant diagnostics from Dovetail Genomics

PRESS RELEASE

UTRECHT, June 2 2022
GenDx has obtained a license from Dovetail Genomics to further develop their Micro-C proximity ligation assay. This modern technology will be a new step improving precision to haplotyping of HLA genes. And, as targeted DNA capture is part of the assay, GenDx will combine this methodology with its extensive knowledge of next-generation sequencing (NGS)-based HLA typing to develop highly attractive products.
HLA typing is a method to determine donor and recipient compatibility and is essential for selecting a suitable donor prior to transplantation. Although current HLA typing can be performed with relatively high accuracy, most methods do not provide any information on which HLA genes were inherited together from a single parent. This determination of genes located together on the same chromosome is called haplotyping and is difficult to achieve using short NGS reads because of the long spans of DNA that occur between the genes.
The GenDx assay, based on Dovetail® Micro-C proximity ligation technology, will be able to determine if a donor and recipient carry the same HLA haplotype. When they do, the chances of an extended match (beyond HLA genes) are much higher, which can potentially lead to a better transplantation outcome.

Wietse Mulder PhD, CEO of GenDx, commented: “Haplotyping of the crucial HLA genes is currently really challenging. The new strategy offered by the Dovetail Micro-C proximity ligation assay now unveils an outlook of better typing options for the HLA field and we believe that transplant patients will finally benefit from this technology ”.

About Proximity Ligation-Based Haplotype Phasing

Proximity ligation approaches have been well known for their ability to capture long-range genomic information. However, they have been unsuitable for genotyping due to significant sequence coverage gaps – traditional approaches miss up to 20% of the human genome. Through re-engineering how the assay is performed, Dovetail Genomics has addressed this shortfall, now enabling SNP phase information to be captured alongside primary genome sequence at coverage levels comparable to or exceeding shotgun libraries. Compatible with targeted enrichment using a hybrid capture panel designed against the 4-Mb HLA region, the technology has been demonstrated to fully capture and phase genetic variation across this entire HLA region.

State-of-art HLA typing analyses rely on comparison of SNP genotyping calls to allele frequency databases to call alleles. Due to the short-range nature of today’s NGS instruments, ambiguity in these calls may exist. Additionally, due to this limited information, it is not possible to resolve parental inheritance. Dovetail’s long-range information inherent to the datatype not only enables more accurate calling for the alleles typed today, but is also capable of fully resolving haplotypes for all genes in the HLA region.

About High-Resolution HLA Typing

The Human Leukocyte Antigen (HLA) system consists of a large family of highly variable genes and many allelic variants which form the basis of the human immunological defense system. In stem cell transplantations, HLA matching of patient and donor is vital, as small differences between HLA alleles may have serious effects on transplantation outcome. High-resolution genotyping is a technology which enables determination of even the smallest variations in HLA genes, making it ideal for stem cell transplantation purposes.

Until recently, Sanger sequencing-based HLA typing was considered the gold standard for high-resolution typing. Today, Next-Generation Sequencing (NGS) has been adopted by the vast majority of HLA laboratories worldwide and has become the new gold standard. This NGS approach offers higher resolution and is more amenable to high-throughput processing.

As one of the pioneering companies in the HLA field, GenDx started offering NGS strategies in 2013, consisting of NGSgo® reagents and the NGSengine® software package for various NGS platforms.
NGSgo®-AmpX was CE marked in 2014, and the NGSgo full workflow compatible with Illumina MiSeq® received the CE mark in 2016. Since 2017, NGSgo & NGSengine are also registered as IVD at Health Canada.

Read full press release here

Changes Under IVDR

GenDx has obtained the CE certificate under the new IVD Regulation (IVDR) for NGSgo® reagents and NGSengine® software (read more about this here).

Although the content of our kits remains the same under the IVDR, there are some important changes regarding:
√ Catalog numbers
√ Kit labels
√ Instructions for use

Changes in catalog numbers

NGSgo-AmpX v2 ● NGSgo-MX6-1 ● NGSengine
Because transitioning from IVDD to IVDR involves major administrative updates, catalog numbers have changed for several products*. Please take note of the following change in catalog numbers:

Although these catalog numbers have changed, the content of these products remains the same.

(*NGSgo-MX11-3 and NGSgo Library Full Kit are also CE marked under the IVDR. Catalog numbers for these products will remain the same, as these products were launched more recently and therefore complied with IVDR from the beginning).

When to start ordering the new catalog numbers?

NGSgo-AmpX v2 ● NGSgo-MX6-1 ● NGSengine
You can start ordering NGSgo-AmpX v2, NGSgo-MX6-1, and NGSengine under the new catalog numbers from June 15, 2022. To allow a transitioning period, ordering under the old catalog numbers remains possible until December 1, 2022. However, we would like to urge you to switch to the new numbers as soon as possible.

NGSgo-MX11-3 ● NGSgo Library Full Kit
We will start shipping NGSgo-MX11-3 and NGSgo Library Full Kit under the IVDR from June 15, 2022. As these catalog numbers do not change, this does not involve any ordering changes for you.

Changes in kit labels

New UDI code
Under the IVDR, product labels will contain a Unique Device Identifier (UDI). This is a barcode consisting of the following parts:
(01) product code (unique for each catalog number)
(10) lot number
(17) expiration date in YYMMDD format, where DD is 00 if day is not specified

You will find the UDI code on the kit labels for unambiguous identification of the kits in order to facilitate their traceability. For NGSengine, the UDI code will be displayed numerically on the splash screen of the software and will include the software version.

New label design

Labels have been slightly redesigned, including re-organization of symbols. New is a link to the location of the electronic version of the Instructions for Use: www.gendx.com/ifu.

Instructions for Use

New IFU versions

There are new versions of the Instructions for Use (IFU) for our IVDR products. The main changes in these versions include an updated intended purpose and additional product information. The laboratory protocols have not changed.
Next to English, these new versions of the IFUs will become available in various other European languages.

No printed IFU in kit

Under the IVDR, we are no longer including a printed version of the IFU in the kit. Instead, you can download the IFU from www.gendx.com/ifu.
If you do need an IFU in paper form, just send a request to support@gendx.com and we will ship a printed copy.

Need help or more information?
If you need any help or would like to have more information, please contact us at marketing@gendx.com

The first company in the field of transplant diagnostics complying with the new IVDR in Europe

PRESS RELEASE

We are very excited to share with you that we received the EU Quality Management Certificate (IVDR) by our notified body Tüv Süd for diagnostic use of our HLA product portfolio. This new IVDR (EU) 2017/746 sets increased standards of quality and safety for diagnostic use of medical devices to ensure the highest level of public health protection.

The IVD Regulation retains all existing IVD Directive requirements, and includes new stringent additional  conditions for in vitro diagnostic devices. Establishing increased quality management, continuous evaluation during the products life cycle and more technical documentation to prove effectiveness are included now. The GenDx HLA portfolio under IVDR contains NGSgo® reagents and NGSengine® software for high-resolution HLA typing. Being one of the first to get certified under the IVDR sets a bench mark for similar products in the field of HLA typing, especially for stand-alone software.

Given the complexity of capturing validation data and building extensive dossiers to obtain IVDR certification, only a few IVD companies have obtained this new certification. The majority of manufacturers is still in the process to implement and prove IVDR compliance for their products.

Therefore, the EU decided recently that, although the effective date of 26 May 2022 remains unchanged, under certain conditions, manufacturers will receive more time to transition to the IVDR. This also applies for GenDx’s chimerism monitoring products, currently CE self-marked under the IVDD.

Wietse Mulder PhD, CEO of GenDx, commented: ‘After a few years of extensive teamwork, we are proud to be the first global supplier in the field of transplant diagnostics, being able to offer a full HLA workflow portfolio under the new IVD Regulation. As a result we can continue to provide our customers with certified products, claiming increased safety and offer improved quality, that will finally benefit transplant patients”.

Read full press release here

GenDx, has received the medical device license from Health Canada for in vitro diagnostic use of NSGgo®-MX11-3.
NGSgo-MX11-3 provides multiplexed genotyping of 11 HLA loci with incredible speed and high accuracy, contributing to the success of stem cell transplantation. In addition, NGSgo-MX11-3 offers the highest available gene coverage of any HLA multiplex strategy on the market.

This is the third NGS assay GenDx has registered in Canada as IVD, following NGSgo®-AmpX v2 for genotyping of 11 individual HLA genes, and NGSgo®-MX6-1 for multiplexed genotyping of six HLA genes. The amplification aims to obtain high-resolution HLA genotyping information by means of downstream sequencing applications with Illumina MiSeq®, and genotype analysis with our IVD-registered NGSengine® software.

By obtaining the Health Canada license, GenDx completes registration of the NGSgo® product line. This line encompasses the first IVD products in Canada that employ NGS-based HLA typing and is suitable for diagnostic use. This product line enables better matching of donors and patients in need of a stem cell transplantation.

Wietse Mulder PhD, CEO of GenDx, commented: ‘we are proud to be the first supplier in Canada that can offer a broad range of IVD registered NGS products for the transplant community. Now, users can pick their own amplification preference. This latest addition of MX11-3 fits into the trend of applying multiplexed amplification and sequencing of 11 HLA genes of every patient and donor in a single run’.

Read full press release in Genomeweb here

Other IVD registrations

In Serbia, with the help of our Serbian distributor,Jasika d.o.o., we can now offer the entire NGS family, represented by NGSgo-AmpX v2, NGSgo-MX6-1, NGSgo-MX11-3, NGSgo Library Full Kit, and NGSengine for diagnostic purposes.

In Malaysia, together with our distributor Stem Molecular Diagnostics Sdn Bhd, we completed the registration for NGSgo®-MX6-1 and NGSgo® Library Full Kit which can from now on be offered also as IVD.

NGSengine® has been updated

Version 2.25.0 includes new features and improvements, and the IMGT/HLA database 3.47. We are also excited to share that from now on, the user interface is also available in French, Spanish, German, and Italian.

Update now!

Make sure to update your software to the latest version to have access to the new features and the latest database. For a complete overview of all changes, please check the release certificate.

NGSengine release certificate
NGSignition release certificate

You can find the latest NGSengine IFUs here (CE, Edition 12) and here (RUO, Edition 12), and the latest NGSignition IFU here (Edition 6).

GenDx and Stichting Incubator Utrecht have signed a rental agreement for the top three floors of the Alexander Numan Building. GenDx is a global leader in molecular diagnostics for matching stem cell transplant patients with donors and since 2006 expanding gradually with more office and lab space.

To accommodate 75+ employees today and provide room for R&D, IVD production and logistics, another enlargement was required again. In addition to the 3^rd floor, GenDx will get about 3000m² at its disposal as a welcome replacement for the currently used office and laboratory space in the Androclus building.

Having all activities in a single building with an own conference room and catering will ease collaboration and offer room for further expansion in the near future. As soon as the current tenants have moved to the Accelerator building, GenDx will start adjusting the facilities and expects to be fully operational in the first quarter of 2023.

Read the full press release here

We have improved our NGSgo-AmpX KIR kit, which includes a few protocol changes to benefit the robustness of the protocol.

This change will take effect from your next order (kit lot# 22000148 and up). Individual primer tubes can be recognized by the indication of the no. of reactions on the tube label instead of the previous dissolving volume.

Benefits

• Hemato-oncology diagnostic assays
• Targeting leukemia molecular markers

Description

In collaboration with University Medical Center of Utrecht (UMCU), GenDx has added a new assay to its product portfolio which is tailored for detecting genetic markers in blood cancers. NGSgo ONCOdentify® identifies mutations within the JAK2, CALR and MPL genes, valuable for the prognosis and selecting treatment options for myeloproliferative neoplasm (MPN).  In the coming period, UMCU will validate these new assays in their routine laboratory work.

The MPN kit is the first of a series of assays to detect somatic mutations related to hematological malignancies like acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic lymphocytic leukemia (CLL). The test can be used on Illumina sequencing platforms.

Next generation sequencing (NGS) offers advantages in accuracy, sensitivity, and speed with the potential to significantly impact the field of oncology. Because NGS can cope with a multiplexed approach of genes in a single assay, it reduces the number of multiple tests as an efficient and fast way to identify the causative mutation.

Wietse Mulder PhD, CEO of GenDx says: ‘Anchored on extensive knowledge of developing software and reagents for accurate HLA typing, we can now offer NGSgo ONCOdentify as a highly sensitive assay for detection of mutations in a tumor sample. We are convinced that this assay is a valuable contribution to improve tailor made treatment of blood cancers. ONCOdentify is now launched as Research Use Only (RUO), but we are in the process of validating it for In Vitro Diagnostic (IVD) device’.

Interested? Contact us for additional information, we will be happy to answer your questions! The product will become available for sale in the coming year.

Find the complete press release here

GenDx is organizing a virtual training course to help you become an NGS HLA typing expert in just 3 mornings.

The course will start with the basics of NGS HLA typing and move up to an advanced level. They include the theoretical background of NGS, a practical workflow demonstration via videos, and extensive NGSengine software training.

So, are you interested in expanding your knowledge of high-resolution HLA tissue typing?

Register now, limited seats available:

Become an expert in NGS HLA typing , February 23-25, 2022

Stay up-to-date on all our educational events by frequently checking our website: GenDx.com/education.
If you have any questions, please contact us directly via education@gendx.com.

Prof dr. Hidetoshi Inoko

★ 4th of January 1948 – † 3rd of January 2022

Recently the sad news reached us that Prof. Hidetoshi Inoko has passed away. Professor Inoko was a pioneer in unravelling the genetic complexity of the MHC region at a time that the current methods for genetic analysis were not available.
Later he was involved in all aspects of MHC, such as evolution, anthropology, diversity disease association and transplantation.
He also had major functions and important influence in the HLA society.
Prof Inoko was a great inspiration to both of us which we will cherish.

Wietse Mulder and Erik Rozemuller

Message from American Society for Histocompatibility and Immunogenetics: 

It’s with sadness that we inform you of the passing of Hidetoshi Inoko. The following tribute was written by Seiamak Bahram and John Trowsdale.

In this age it is easy to forget just how tortuous analysis of human immunogenetics used to be but in fact most of the fundamental discoveries about the MHC  genes were made before high throughput sequencing came onstream. Hidetoshi Inoko recognised the value of large-scale structural analysis of the MHC region, in man as well as other species, in the 1980’s and was a great contributor to the advancement of our field before he contributed to the first sequencing of the complex in 1999. From 1990 he was an early adopter of DNA typing for histocompatibility. The other approach he exploited for disease mapping on a genome scale was that of polymorphic microsatellites, which led to one of the very first Genome Wide Association Studies (GWAS) ever performed, that of rheumatoid arthritis using over 27000 microsatellites, a major tour de force at the time (2005).

From 1966 to 1976 Professor Inoko did his BSc and PhD (Science) degrees at Kyoto University, followed by eight years at Keio before moving to Tokai in 1984. He spent a year in Trowsdale’s laboratory in London at Cancer Research UK (then ICRF) in 1986-7 and qualified for a PhD in Medical Science in 1987. He became a Professor in 1992. His leadership qualities were recognised as he was elected Chairman of the Department of Molecular Life Science in Tokai University’s School of Medicine in 1993 and Vice-Dean in 2000, followed by Dean of the Graduate School in 2002 and then of the School of Medicine in 2006, when he was also director of the Institute of Medical Sciences. In 2021 Hide become Project Professor of the Center for iPS Cell Research and Application (CiRA) and Emeritus Professor of Tokai University in 2013. He co-led, in the past 10 years, with Seiamak Bahram, the only French-Japanese joint INSERM-JSPS laboratory, focused on histocompatibility.

Professor Inoko was a Councillor for the International HLA and Immunogenetics workshops and he played a major role in several of these successful large-scale events as well as in the Asia-Oceania Histocompatibility and Immunogenetics Workshops. He was also President of the Japanese Society for Histocompatibility and Immunogenetics. A committed educator, he was a visiting lecturer in several Japanese Institutes as well as abroad.

As a work colleague Hide was unique, a friend larger than life. He enjoyed the pleasures of international travel, of companionship as well as Scotch whiskey and red Burgundy. He was also an avid golf player. Many of us were recipients of his generous hospitality and kindness in hosting visitors in Japan where he was active 18 hours a day to make sure his guests experienced the best of Japanese culture. Hide worked and played extremely hard and was always cheerful and open-minded.

Seiamak Bahram and John Trowsdale

This week we have received the registration certificate from the Ministry of Health for the registration of the leading products of GenDx as IVDs in Belarus.

In close collaboration with our Russian distributor BioChemMack, we can now offer the entire NGSgo® family, represented by NGSgo-AmpX v2, NGSgo-MX6-1, NGSgo-MX11-3 and NGSgo Library Full Kit, for diagnostic purposes in Belarus.

Of course, the AlleleSEQR® product line for Sanger sequencing is still available as IVD as well.

Together with you, we are starting this new year with confidence and great expectations.

We just want to say a big thank you for your continued trust and collaboration in 2021, yet another challenging year, but filled with big accomplishments. Although the battle against COVID-19 is not over yet, nor are our lives back to ‘normal’, we have found new and successful solutions to keep in touch and collaborate remotely.

We took use of the power of the online world and realized we had to connect even stronger than before. We hosted a record number of webinars, virtual education sessions, and online demonstrations. Meanwhile, our R&D team achieved several milestones with respect to our product portfolio which will ease your lab activities.

The future ahead

In 2022 we expect to develop more innovative products, contributing to the best possible performance for our users. Be prepared for news about usage of our products on several NGS platforms and the possibility to obtain results within a day. Paired with the continuous improvement of our online activities, we are optimistic that we can attend meetings in person and get to be truly present once more. Obviously, we will continue to strive for excellent customer support, answering any questions that may arise.

Very good news is the expected IVDR compliance and registration which will be valid from May on, also being a strong quality argument for our products in non-European Countries. We are also excited to extend our product portfolio from its solid NGS base for efficient multiplexed HLA amplification and chimerism monitoring. In addition, the interest for HLA-loss is a huge pacesetter for post-transplant monitoring, either by NGS or PCR. And our renowned NGSengine® software will be your key to uncover blood group typing.

Our USA customers and contacts will benefit from a larger GenDx team set up in Chicago and we are all thrilled to meet a lot of you during the EFI2022 conference in May, happening in Amsterdam in our home country. We secured a premium spot as GenDx is the single diamond sponsor of this meeting. Stay tuned for our educational activities and not to forget: the renowned GenDx Tulip Run.

We are starting this exciting new year with a driven focus on excellence and as always we look forward to continue our collaboration with you to advance the field of transplantation and support the HLA community.

Stay safe and we wish you a successful Happy New year!

Sincerely,

Wietse Mulder PhD, CEO

Genome Diagnostics B.V., also known as GenDx, is now launching NGStrack® and TRKengine®, its newest RUO (Research Use Only) marked reagents and software for chimerism monitoring by NGS (next-generation sequencing). This method can be used as an alternative for the current conventional STR (short tandem repeat) technique, with NGStrack being significantly more sensitive. NGStrack provides reliable chimerism data, at both high and low percentages.

NGStrack makes use of 32 so-called indel markers to distinguish between donor and recipient, based on inserted or deleted DNA fragments. Together the 32 indels cover 362 distinctive nucleotide positions across 18 chromosomes, including X/Y chromosomes. Only minimal amounts of DNA are required from the pre-sample, since it only needs to be tested during the initial step of determining informative markers. This prevents a potential run out of pre-sample DNA during the monitoring phase.

TRKengine software interprets the informativity of the markers and quantifies the chimerism percentage in post-samples. Its use as data management system allows for insightful chimerism monitoring and trending over time.

The NGStrack markers overlap with the existing GenDx qPCR kits for chimerism monitoring (KMRtype® and KMRtrack®), therefore it is possible to use both methods in parallel. NGStrack reagents and TRKengine software are compatible with Illumina sequencing platforms. As such, NGStrack can easily be included in our renowned NGSgo® workflow that has been successfully used in HLA labs for many years.

Dr. Wietse Mulder, CEO of GenDx, commented: “We are thrilled to offer these products to the market, enabling users to combine their routine NGS for HLA typing with chimerism monitoring. As of today, the field has the choice to replace conventional STR by a far more efficient and effective technique!”

Ready to start chimerism monitoring by NGS? Contact us for additional information, we will be happy to answer your questions!

Read more about NGStrack and TRKengine here

Find the complete press release here

GenDx is excited to announce the appointment of Ass. Prof. Iwijn De Vlaminck as Scientific Advisor. De Vlaminck is renowned for his extensive expertise with cell-free DNA/RNA detection. This can be applied to new groundbreaking methods, including monitoring the outcome of transplantation.

Dr. Iwijn De Vlaminck joined the faculty of the Meinig School of Biomedical Engineering at Cornell University in 2015. His research at Cornell focuses on the development of precision medicine technologies for the monitoring of infectious diseases and immune-related complications. De Vlaminck obtained a PhD in Science and Engineering from the KU Leuven in Belgium. He received postdoctoral training in the labs of Stephen Quake at Stanford University, USA, and Cees Dekker at the TU Delft, The Netherlands. He was awarded the NIH Director’s New Innovator Award in 2017 and the Robert Noyce Assistant Professorship in 2015.

De Vlaminck’s research focuses on the development of molecular analysis technologies for microbiology and immunology. He applies these technologies in the monitoring of infectious diseases and immune-related complications. His research is highly interdisciplinary in nature. This results in innovative applications in genomics, computational biology, and molecular engineering. GenDx expects that his knowledge of cell-free DNA as an upcoming biomarker in transplantation will be of great importance. It will aid in developing cutting edge products that improve transplantation outcomes.

With De Vlaminck, the Scientific Advisory Board of GenDx now consists of four top-level qualified members. These include Em. Prof. John Trowsdale PhD, Prof. Seiamak Bahram PhD, and Em. Prof. Frans Claas PhD. They cover fields such as precision medicine technologies, MHC immunogenetics, non-conventional histocompatibility genes, blood groups, immunohematology, and blood transfusion.

Dr. Wietse Mulder (CEO of GenDx):

“We are extremely honored and delighted to have Iwijn De Vlaminck in our scientific advisory board. His knowledge and view on the HLA lab of the future were recently shown during the annual ASHI meeting in Orlando. These will be extremely useful to enthuse our R&D team further. I’m looking forward to jointly develop new strategies which we expect that these will contribute to the quality of life and survival of transplant patients”.

WAGENINGEN, 29^th October 2021 – Diagnostic startup company Scope Biosciences B.V. has raised €1M funding from Utrecht based GenDx, specialized in Next Generation Sequencing (NGS) products for transplant diagnostics.

Elaborating on the work of Dutch Spinoza-winning scientist prof. dr. John van der Oost and ass. prof. dr. Raymond Staals at Wageningen University, Scope Biosciences applies CRISPR-Cas’ inherent specificity and ease of use to develop a molecular diagnostic platform. This will revolutionize the field of diagnostics as the simplicity of the assay promises to bring highly accurate molecular diagnostics outside the research laboratory like clinical bedside applications.

Scope Biosciences will benefit from GenDx’ experience to speed up developing and marketing the ScopeDx platform. Furthermore, Scope Biosciences plans to use the funding to grow its research and development team, and expand on the running partnerships in the development of rapid diagnostics for infectious diseases in healthcare, veterinary and agri-food applications.

The collaboration with GenDx is mutually beneficial, as it will entail a co-development trajectory to develop ScopeDx applications for transplant diagnostics.

Dr. Wietse Mulder (CEO of GenDx):

“We are excited to collaborate with such a motivated and energetic team of Scope Biosciences that is supported by WUR, the renowned scientists Van der Oost and Staals and the seasoned businessmen Math Kohnen and Wil Hazenberg. We truly believe that together with them both Scope Biosciences and GenDx will be able to deliver meaningful products to the field of diagnostics based on CRISPR-Cas technology.”

Niek Savelkoul (CEO of Scope Biosciences):

“The proprietary ScopeDx CRISPR-diagnostic platform has shown its incredible potential in various applications in the last 3 years of its development, and with this investment we can bring the first ScopeDx products to the market. We are delighted to see such excitement from GenDx who recognize the potential of the ScopeDx platform technology. We are looking forward to working with and learning from this leading provider of transplant diagnostics.”

The hybrid event took place from September 27 to November 1. We were very happy to see that many of you got in contact with us either in person or in our virtual booth, showing a lot of interest in our products, thank you for that! Some of our materials from the event are now available online and can be found in the links below so feel free to check them out!

Posters

The posters that were presented are now published on our website. Make sure to check them out and get updated with our latest developments. GenDx posters at ASHI 2021

User group meeting

In this year’s UGM we shared with you:

• our latest development on Chimerism monitoring by NGS
• exciting preliminary results of our platform comparison study where long read data from Pacbio and MinION are compared to short-read data
• an update on our newest multiplex strategy NGSgo-MX11-3

For those who have missed it, video is now available upon request

Tulip Run

Until next year at the ASHI 2022 in Las Vegas!

NGSengine has been updated!

We have released the new version of our NGSengine software. Version 2.23.1 includes several new features and improvements, and the latest IMGT/HLA database 3.45.1.

HML exporter now available

To facilitate the digital reporting of HLA testing results and the collection of the raw probe, primer, and sequence data, the NMDP Bioinformatics group developed a software reporting format in 1998 but maintenance and extension became increasingly difficult due to the rigid format limitations. Therefore, the NMDP Bioinformatics group developed an XML-based reporting format to address the shortcomings of the previous format. The XML-based format is called Histoimmunogenetics Markup Language (HML) and is intended as a potentially general-purpose format for exchanging genetic typing data.

From the version 2.23.1 of NGSengine onwards, you will be able to export the typing results also in HML format. This has been a long-awaited feature as HML is the format of choice to upload data in the IHIW 18 workshop, to which GenDx is a sponsor and official partner. Now any user of NGSengine will be able to create a .hml file and contribute to the database maintained by the workshop promoting research, science, and exchange of valuable data.

Interested?

For more information regarding the HML format check the publication “Histoimmunogenetics Markup Language 1.0: Reporting next generation sequencing-based HLA and KIR genotyping” or directly contact us at marketing@gendx.com

Download NGSengine 2.23.1

New NGSengine tutorial videos are now available on the GenDx website in the Education section. Are you a new NGSengine user and want to become familiar with the software? Or are you an experienced user in need of a refresher or some extra help? Watch our videos and become an NGSengine expert!

The videos include all the latest features of NGSengine, as well as updated graphics that make the videos easier to follow.

Enjoy!

Watch the new instructional videos

Gerben Cramer is a 25-year-old student, currently enrolled in the master’s program ‘Public Sector Management’, and living in Leiden, The Netherlands.

In the summer of 2020, Gerben did something extraordinary: he donated his stem cells to an anonymous patient. We wanted to learn more about what it can be like to be a stem cell donor, and were happy to get in touch with Gerben. Enjoy reading!

When and why did you decide to register as a stem cell donor?
In January 2020, a good friend of mine sent a message in a group WhatsApp, sharing the story of a friend of his, who underwent a stem cell transplant as a treatment for leukemia. The road to receiving the transplant was a bumpy one, as the initial stem cell donor cancelled last minute. As a result, they had to consider finding an eligible donor within the family. The mother turned out to be the best fit, but given her age, it was a risky procedure. Fortunately, the transplant went well, and the patient survived. My friend concluded his story by saying: “Guys, please consider registering yourself as a stem cell donor, because my friend is luckily still alive, but there are still so many patients looking for a stem cell donor.” For me, this message was reason enough to sign up. I joined the registry the next day.

“For me, that message was reason enough to sign up. I joined the registry the next day.”

You were not registered for that long when you got the call?
Indeed! I was pretty surprised that Matchis reached out to me in March 2020. I did not expect to hear from them so quickly. They told me that it was indeed very unusual, but at that moment there was someone, somewhere in the world, in need of a stem cell transplant… and I was one of the five potential donors selected from the database. So then they examined my blood, and there was a more in-depth medical examination, questions about daily life, and my motivations. In the end, I turned out to be the best match for the patient.

What went through your mind when you heard that you were the best match?
Well, they asked me “Are you sure? Are you sure that you want to do this?”. I did not really understand the question, because I thought “Of course! There is a match, and I read that there’s only a 1 : 50.000 chance that you are selected as donor”. What was on top of mind for me, was that if I could help someone, I should do it. I found it amazing that I could do it, so I thought let’s go! Of course, I was also a bit nervous, but mostly I was grateful that I got to be the one to do this.

What do you think about the way you were informed about the procedure in general and the associated risks?
The guidance from Matchis was super good. They really took the time, checked in on how I was doing and how I felt about things, and were honest about the procedure and potential risks. Right from the start, a buddy from Matchis was assigned to me. I could really ask her anything, and she was there on the day of the transplant. That was really nice! They also arranged for a taxi to pick me up and get me back home. Everything is very well organized. Of course you are making an effort by being a donor, but still. It feels like a token of appreciation; they are happy that you are willing to do it.

Was there anything in particular that you were nervous about?
Yes, I was nervous about certain side effects. Personally, I was happy that my stem cells were taken from my blood, as there are less side effects associated with this method than donation via the bone marrow. But, in my opinion, the risk comes with the job, and I wanted to do the job.

Who decides whether stem cells are taken from blood or bone marrow?
You can indicate your preference, but eventually it is up to the patient’s doctor which method will be best for the patient. For example, for very small children, a stem cell transplant via the blood is more invasive than via the bone marrow. For older patients, the majority of transplant procedures are in the form of a blood transfusion.

What did the donation procedure look like? And how did you experience it?
72 hours before arriving at the hospital, you have to start with injecting a growth factor drug, to stimulate the body to make more stem cells. Someone from home health care (thuiszorg) came to my house to explain everything. The growth factors needed to be injected in my belly twice a day and fortunately my friends were willing to help me as it felt a little strange doing it myself at some point. Luckily, I did not experience too many unpleasant effects, whereas others do experience muscle and back pain. I was happy to start the donation relatively fit.

On donation day, 09.00AM, I arrived at the hospital. I took a seat, needles were injected in both arms, and then they started the transfusion; three rounds in total.

I found it a bit hard not to know the person for which I was doing this. It was someone, somewhere in the world, but that was all I knew; it remains anonymous. At some point during the day, they told me the patient’s gender and age. Also, I learned that the patient was on the heavier side, which meant that he needed more stem cells than the average person. So, it depends on how many stem cells are required for the patient whether the donation takes shorter or longer. For me, it took until 5.00PM.

My body had been working the whole day, and you basically ‘loose something’, so I was pretty exhausted.

“Only when I heard the good news about the patient doing well, it all felt more ‘real’ and personal. That’s when it really kicked in”

What was the donation like, on a more emotional level?
During the donation, I felt a little bit ‘distanced’ from the cause; you are laying there and at the end of the day, a courier comes along to pick up the stem cells. When I got back home, sitting on the couch, I really felt how tired I was. I could not tell too many people about the transplant, because of anonymity measures. Also, donor and patient can send each other a message, post donation, but that is all anonymous, so for all you know he might live as far away as Madagascar, or something. So, I just continued my life as normal, while I expected that what I just did would feel more special, but that was not really the case.

Only when I heard the good news about the patient doing well (6 months after the donation), it all felt more ‘real’ and personal. For me, it was at that exact moment that it ‘kicked in’. I do not mean this in an arrogant or selfish way, but I realized that the patient survived, because of MY stem cells. That felt so special.

“If I get the chance to make a difference again, I would do it. Without a doubt.”

Would you do it again? What if you turn out to be a good match for someone else in need?
Yes. Without a doubt! I have told my story to many others, hoping to inspire them to register as a stem cell donor as well, and if I get the chance to make a difference again, I would do it.

Let’s go!

Actually, after the donation, I was asked whether I would be willing to donate more stem cells or white blood cells for the patient, when needed. And of course I said ‘yes’. Typically, something like this would happen about 3 months after the donation. It didn’t happen eventually.

How long did the recovery process take for you?
Not that long, actually. Two days, max. But other than feeling tired, I did not experience any side effects. For the first 6 months after the donation, they make sure to check how you are doing on a monthly basis. After that, only every 6 months, and at a certain point it’s once a year. This way they can monitor whether there are any late side effects occurring after the donation. I definitely appreciate that they are checking in on me!

What would you like to say to people who are not sure if they want to become a potential stem cell donor? For example, people who are a bit scared of the procedure?
I can only speak from my own experience. I think it is most important to inform people, and I feel honored to be able to share my story and information on stem cell donation. Still, to be honest, sometimes I think: “Come on! There are patients, with leukemia for example, waiting for a stem cell donor. Just do it! You can potentially save a life!”… But even though I think everybody should sign up, everyone eventually has to make their own decision.

“The choice is yours, but actually you should just do it”

I really would like to say that the guidance from the Matchis foundation throughout the whole trajectory is absolutely superb. They are very professional and they really show their appreciation for the donors. I experienced that every nurse, every doctor, they all said “Thank you”, so I felt really valued. On the one hand, you are doing something really significant, and on the other hand, it is such a small effort… There is only a small chance that you are matched with a patient, but when you get the call, you can give a chance at life!

That is a beautiful conclusion. Thank you so much for sharing your story, Gerben!

———

Are you inspired to become a stem cell donor and give someone a chance to live? Go to www.GenDx.com/stem-cell-donation/ to learn more about how you can register.

Frans Paymans (61) is a former professional soccer player and a two-time cancer survivor.

He got diagnosed with non-Hodgkin’s mantle cell lymphoma in 2011. Back then, Frans was treated by means of his own stem cells. Unfortunately, the disease came back in 2016, and thanks to a match with someone from the stem cell donor registry, Frans was able to recover from the cancer. The battle was not over yet, due to graft-versus-host disease. This implies that donated cells (the graft) see the recipient’s cells (the host) as foreign and attack them; a reverse rejection so to say. Luckily, Frans fully recovered from this as well, and was able to go on. Nowadays, Frans is working as location manager on a school for special education. He is committed to keep raising awareness on the importance of stem cell donation, and associated topics.

“Eventually, it comes down to luck, and I have been extremely lucky!”

When were you diagnosed with cancer for the first time?
In 2010, I went to see a doctor after discovering a bump in my inguinal area. That turned out to be a swollen lymph node. In June 2011, I was diagnosed with non-Hodgkin’s mantle cell lymphoma, which is a relatively uncommon type of cancer that affects the lymphatic system and damaged about three-quarter of my bone marrow. By the end of July 2011, the treatment started at the Radboud University Medical Center in Nijmegen, The Netherlands. The first stem cell transplant was on January 24^th 2012, and those were my own stem cells.

Wait… what? Your own stem cells?
Yes, my own stem cells! It is called an ‘autologous’ stem cell transplant. The procedure is similar to when a donor goes through the donation process, involving growth factor drug injections to stimulate stem cell production. I first received chemotherapy, and that basically destroys your body, so I had just enough healthy stem cells that could be filtered out and collected by means of an apheresis machine. Eventually, your own stem cells are returned to the body through infusion. It cured me, but unfortunately the cancer came back completely in 2016.

What was the treatment like the second time around?
They went looking for a donor and, luckily, they found a very good match in the stem cell donor database; a young woman from the United States. Our blood group and HLA matched perfectly for the purpose of a stem cell transplant. Thanks to her donation, which was on October 10^th 2016, I received the stem cells on October 11^th 2016. I recently had my final check up with ‘my’ doctor. She and her team have been of unbelievable value. From now on, I only need to visit the outpatient department with longer intervals. They still need to monitor you, as there can potentially be residual effects from chemo, even after 10 years. Other than that, all is well.

How did you experience receiving stem cells from someone you do not even know?
I was pretty naïve at first, as I thought that getting stem cells was ‘as easy as buying a bread from the bakery’, but that turned out not to be the case… I was extremely lucky to match with a donor from the registry, and that donor is the reason I am sitting here, having this conversation with you, and the reason I can do everything I want to do.

And that’s why, a couple of years ago, when I was sitting on the top of a mountain in Norway, with my wife, I decided to share my story by publishing a book. A book about 60 years on this earth, and what it all meant to me and what it has brought me. And the ultimate goal was to donate part of the profits to Matchis and KWF Dutch Cancer Society.

The book is titled “It is a Competition” (Het is een Wedstrijd). What was it like to write that book? And, If I may say so, I get the feeling that to you, the battle has not yet ended…
It was a nice thing to do, but it was also very confronting, both regarding the period I was sick and the period prior to that. My main motivator to write this book was the thought of all those who do not live to tell about it.

And yes, on the one hand the battle is over, as last year I was able to leave quite some things behind me. All that’s left, is the possibility of residual effects from the chemo therapy that I had back in 2011. But, on the other hand, there is still a need to increase the chances for others to find their perfect match, that battle will never be over. I am committed to raise as much awareness about the topic as possible, and I really want to motivate people to register themselves as a stem cell donor at Matchis.

Looking back to the moment you just got the diagnosis. You told me that you did not know what you were up against at first. How did you cope with that? And what were your first experiences during treatment?
Well, my wife is a nurse and she pretty much knew what was coming, but initially, I had no idea what I was up against. After the diagnosis, driving back home in our car , there was an item on ‘Alpe D’HuZes’ on the radio. That was the first time I truly realized what that initiative was for, and that really hit me hard. When we got home, we first had a good cry. Then, the questions started coming: “What does this all mean? Am I going to survive this? Will I live to see my grandchildren?”. My wife and I met in 2010, and in June 2011 I got the diagnosis, so we had not been together for that long. We wrote down all our questions, and contacted my doctor, who was willing to discuss everything we wanted to know. What I really appreciated, is that she was transparent and straightforward.

At some point, after chemo started, I woke up looking at my pillow covered with plucks of hair that had fallen out. I realized at that moment that this was a first tangible result of the chemo. I had a couple of outpatient treatments, but at some point I was in the hospital for about 78 days, divided over 3 hospital admissions. Both the treatment and recovering from the treatment was, to put it mildly, not always the most pleasant experience. Basically, all that’s left is a body with a beating heart. You feel exhausted. You do not have any energy to do anything, not even to take a shower in the morning.

“Basically, after chemo, all that’s left is a body with a beating heart. You feel exhausted.”

Would you say that your athlete mentality benefited you throughout the whole trajectory?
Yes, I definitely think that my love for sports helped me back then, and that motivated me to get on the home trainer at least 2 and sometimes 3 times per day, for about 15-20 minutes. I did this to keep myself busy, but was also hoping it would contribute to my recovery. Still, eventually it comes down to luck, and I have been extremely lucky.

Actually, around the time I got my first treatment, in 2011, they started with research regarding the effects of working out prior to cancer treatment. I believe that nowadays, health insurances are covering costs for personal training for people who need to get treatment so they will start at a higher fitness baseline. So, that is a beautiful development, if you ask me.

What else helped you to get through the treatment and recovery?
My wife. She was there for me. You really need that ‘second person’ to be there during meetings with the doctor, as you are only able to process half of what they are telling you. The role of the partner is extremely important, and sometimes even underexposed. Imagine what they are going through: keeping their day to day life running, commute to and from the hospital, worrying about you and going to bed alone, scared that you might not be there anymore when they wake up the next day…  That is extremely hard and I think there should be more awareness about this as well.

Also, what I remember very vividly, is something that happened in 2012, when I was doing extremely unwell. My old soccer team, N.E.C. Nijmegen, played against my favorite soccer team, Feyenoord. There was a gigantic banner, put up by the crowd in the stadium, that said: “Frans, keep fighting” along with a huge painting of my face. It touched me deeply. I got so many messages after that. The original banner is completely weathered by now. To my surprise, the boys who made the original banner gifted me a small replica, on canvas, a short while ago. That was heartwarming.

I learned that it is possible to send an anonymous letter to the donor. Did you do that?
Not yet… it did cross our minds many times already, but it wasn’t the right time. In October 2021, it will be exactly 5 years ago that I got the stem cell transplant, so we are planning to send the letter then. A short while ago, during the “Stamweek”, I got the chance to read out loud part of the letter to my donor, live on radio station 3FM. That was very special.
The people from Matchis and the Radboud UMC stem cell consultants will be translating the final letter for me, and make sure there is no information in it that can be traced back to me. They will then send the letter to my donor.

Why did you decide to wait for the five year mark?
Things can still go wrong. And for me, it did. When I was finally cured from cancer, I got graft versus host disease, which made me very sick – it felt like I died a few times. Fortunately, after a lot of research, they were able to cure me from that. So, that also confirmed that waiting for that so-called ‘magical’ five year mark before contacting the donor, was a good decision.

“I did not have any control over my own body. I felt desperate and powerless.”

That must have been real hard, to get so sick after healing from cancer…
I did not have any control over my own body. It mainly affected my gut and later on also my skin.  I felt desperate and powerless. I was extremely dehydrated, and I had random blackouts that I did not even consciously experience. It was horrible. Fortunately, I fully recovered and can now enjoy the outdoors, biking and walking again.

To conclude, what would you like to say to people who are considering to become a stem cell donor, or who are still hesitating?
The beauty of this day and age, is that most of stem cell donations are taken via blood. In only a small proportion of donations, stem cells are taken from bone marrow. Most people can donate via blood, which involves growth factor drug injections, followed by harvesting by means of the apheresis machine. This procedure typically comes with mild, flu-like side effects that last only a couple of days. Then it is gone. So, if you are willing to pay that relatively small price, to really make a difference for a patient in need of a stem cell transplant, please… do not miss out on that opportunity! There are so many people who deserve it, just as I was lucky enough to receive stem cells from that young woman in the US. To all young men and women: let’s go, come on, please, join the registry!

——-

We thank Frans for taking the time to meet with us, and hope that you are as impressed with his story as we are. If you want to read Frans’ full story, you can go to his website: www.franspaymans.nl.

Are you inspired to become a stem cell donor and give someone a chance to live? Go to www.GenDx.com/stem-cell-donation/ to learn more about how you can register.

NGSengine has been updated!

We have released the new version of our NGSengine software. Version 2.22.0 includes several new features and improvements, and the latest IMGT/HLA database 3.44.1.

Some important new features

• Analysis of NGSgo®-MX6-1 and long-read alignment have been significantly improved.
• IMGT/HLA database 3.44.1 is included and selected by default.
• Improved the security of user credentials.
• All unpublished splice sites are extrapolated with the common nucleotides, which was not the case for DPB1, DPB2 and HLA-H. This will allow easier identification of new splice site variants and putative null alleles.
• At the locus analysis preferences, the “Set all loci like HLA-A” button is changed into a “Set all locus like selected locus” button.
• The name of the saved PDF report is automatically based on the scope (project/ group/ sample/ locus).

Update now!

Make sure to update your software to the latest version to have access to the new features and the latest database. For a complete overview of all new updates, please check the release certificate.

Download Software update

Download Release certificate

£2.029 cheque handed to Beachon Cancer Charity

Thanks to the contributions of the participants of the #EFI2021 virtual Tulip Run and the multiplication from GenDx, EFI president Ann-Margaret Little and her colleague Helen McFarlane were able to hand over a cheque of £2.029 to the Beatson Cancer Charity in Glasgow. COVID restrictions caused a delay in the in-person handover, but happily, it could be realized now.

Grateful thanks to everyone who contributed!

Maisie McCormick, Community Fundraising Manager at Beatson Cancer Charity mentioned: “On behalf of everyone at Beatson Cancer Charity, thank you for your kind and generous donation of £2,096.79 raised through this year’s Tulip Run. What an incredible donation – it just goes to show how your generous clients and contacts used their initiative and got out to do their run wherever they were, despite not being with others. We are thrilled at having received such a fantastic donation. Please pass on our grateful thanks to everyone who contributed in some way. Thanks to your support we can continue to invest in services, staff, research, and education to provide a better future for those affected by cancer”. 

Thank you all for your support and looking forward to meeting you at the next Tulip Run event!

GenDx has registered NGSgo®-MX11-3 as CE-marked IVD

The product can now be used for accurate HLA typing of donors and patients in need of organ or stem cell transplantation. The approval of NGSgo-MX11-3 completes the series of our CE-marked IVD amplification products, including a singleplex (NGSgo®-AmpX v2) and a six-gene multiplex (NGSgo®-MX6-1) strategy for HLA typing by Next-Generation Sequencing (NGS). All amplification products can be used in combination with the recently CE-marked IVD Library Full Kit for indexing, library preparation, and cleanup.

NGSgo-MX11-3
NGSgo-MX11-3 consists of amplification primers for eleven HLA genes (HLA-A, -B, -C, -DRB1, -DQB1 and -DPB1, DRB3/4/5, DQA1, and DPA1). The three-tube design results in low noise levels and well-balanced alleles, providing similar high-quality data with the 11-loci multiplex compared to the singleplex strategy.

Dr. Wietse Mulder, CEO of GenDx, commented: “We are proud to now offer the NGSgo-MX11-3 multiplex amplification for diagnostic use, and we are convinced this innovative product will accelerate the demand for high-quality multiplex data for stem cell transplantation”

Read the complete press release here

Starting from NGSengine version 2.20, the software reports the Bw4/6 status of HLA-B alleles (based on the ALLAN tool*) in the overview, genotype ranking, TARR export, and the PDF report.

We are happy to announce that HistoTrac now accepts the tarr file as input and thus labs are able to transfer the Bw4/6 assignments directly into NGSengine.  In addition, making use of the conclusive typing feature is now compatible with the import as well as the transfer of NMDP codes, if there are ambiguous typings.

Interested?

Contact HistoTrac today to have your module updated so you can make use of this feature.

*Kaur N, Kransdorf EP, Pando MJ, Maiers M, Ray B, Lee J-H, Lalli P, Murphey CL, Bray RA, Gragert L. Mapping molecular HLA typing data to UNOS equivalents. Human Immunology. 2018: doi.or/10.1016/j.humimm.2018.08.002

For those who have faced a deadly disease such as leukemia, it seems like life has been divided into ‘before’ and ‘after’. When you are on the waiting list for a stem cell transplant, you just have to wait and hope a suitable donor will be found. We got to interview leukemia survivor Tom Barendregt (22) about successfully battling this violent disease not once, not twice, but three times. Read more about Tom’s first-hand experience in receiving a stem cell transplantation and his understanding of how crucial it is to have strong spirit during such uncertain times.

Can you tell me a little bit about yourself. What is your life like and how did you get diagnosed with leukemia for the first time?
Before I got diagnosed with leukemia, I played ice hockey on a professional level. On the age of fourteen I already got my first professional contract in the first division of the Netherlands. When I was fifteen, I transferred to the Colorado Thunderbirds in Denver in the United States. I played here for one year, but due to compulsory education, I had to move back to the Netherlands to finish school. While finishing school I played in the Dutch first division again. From the moment I finished school I moved back to the US to play in the USHL, the highest league in the world for guys until the age of 21. Just before the start of the season I started to get weird symptoms like extreme tiredness, bruises on my body and pain in my lower back. I visited multiple doctors and tried different therapies, but nothing seemed to help. I decided to go to the hospital where they took a blood sample. They immediately diagnosed me with leukemia, a disease I had never heard about before. My suggestion was to give me some medication so that I could start the ice hockey season. But when they told me that the leukemia was in a very far stage and that one ice hockey puck to my body could be life threatening, I realized that it was very serious. Instead of starting the ice hockey season, I ended up in the hospital to start chemotherapy. The start of another type of top sport: fighting leukemia.

“I ended up in the hospital to start chemotherapy. The start of another type of top sport: fighting leukemia.”

So when you got diagnosed with leukemia, you were all alone in a foreign country?
Yes, that’s right. The only people that were around at that moment were my host family and my former girlfriend, who was about to start her study in Madison. Since the leukemia was already in a very far stage, it was too risky to fly me back to the Netherlands for treatment. One day after the diagnosis, I was hospitalized in the University Hospital in Madison and my father and the father of my former girlfriend travelled to the US to support me in the process.

Can you tell us something about what you have been going through from the moment you started treatment?
Before I started treatment, I was confronted with the message that the treatment would pose a high risk for infertility. I was 17 years old at that time, so I wasn’t thinking of having children at all. However, to be prepared for a potential wish for children in the future, I was sent into a room with a plastic jar and a playboy magazine. Then we started the induction phase, which is 30 days of chemotherapy. After one week I got a severe allergic reaction that nearly killed me. For the remaining 3-4 weeks they switched to intramuscular chemotherapy, which is given as injection into a muscle. I had many bone marrow punctures and lumbar punctures to see if there was cancer in my brain. Luckily there were no cancer cells in my brain, but they injected chemo there anyway for preventive reasons. After all, leukemia can hide anywhere.

“Leukemia can hide anywhere”

How long did it take until a suitable donor was found and you actually got a transplant?
There are multiple ways to fight leukemia, a stem cell transplantation is not always part of it. In my case, they decided on a treatment without a stem cell transplantation at first, so only chemotherapy and steroids. Four months after my diagnosis, they recognized that my leukemia was pretty aggressive and they therefore decided to change the method and continue with a stem cell transplantation. I consider myself lucky that I quickly matched with multiple donors in the database. When you are more racially mixed, it gets more complicated to find a donor and it often takes months or even years. Time you don’t have when you suffer from a life threatening disease like leukemia. Before you start with the stem cell transplantation, you receive treatment to destroy the cancer cells, your own bone marrow cells, and immune cells. So your body is quite destroyed. Then you get a transplant.

“I consider myself lucky that I quickly matched with multiple donors in the database”

How long did the recovery take place
From the moment you receive the stem cells, you are far from done. First of all you are monitored regularly to measure the effectiveness of the transplantation. In my case, I had pretty severe graft-versus-host symptoms, meaning that the donor T cells were attacking my healthy cells.
After approximately 9 days, they saw that it was starting to work. Exactly two weeks after I got my transplant I left the hospital. This was extremely fast, because normally you’re there for 6-8 weeks. After 3 months they did a bone marrow puncture to check how much of the bone marrow was now from the donor.
The whole transplantation and coping with its side effects took me an additional 7-9 months. And like I said, even when they don’t see the leukemia anymore, it can always come back.

And it did come back… twice.
How did the second and third treatment compare to what you had been through already? Did it start all over again, or was it different from the first time?
With my second diagnosis they suggested a new treatment method called CAR-T therapy. In CAR-T, T-cells are taken from your blood and modified in the lab by adding a man-made receptor. This receptor helps to identify the bad cells.
The third treatment was comparable with my first since I had a stem cell transplantation. In principle these treatments were pretty much the same, the main difference was that with the third treatment they used immunotherapy instead of chemotherapy. Immunotherapy is a relatively new cancer treatment that boosts the immune response in the body as well as teach the immune system how to identify and destroy cancer. The reason why they tried this different method is because there were mutated leukemic cells hiding in my testicle. Since these mutated cells had another genetic code (CD22), it was not recognized by the CD19 CAR-T cells.
An interesting fact is that both with the second and third diagnosis, the leukemic cells were hiding in my testicles. More and more research shows that this is a very common place for the cells to hide in a men’s body, therefore radiation on the testicles is included in the standard treatment procedure in the US. Upon my last treatment, I had twelve radiation sessions on my testicles just before the transplantation. This was to minimize the chance that leukemic cells were able to hide there again.

Your third fight against leukemia was during the first months of COVID-19. Since your immune system was (about to be) killed by chemo, were you afraid that COVID-19 could get to you? |
When you are in the process of radiation and stem cell transplantation, a cold is already dangerous to you. So you are very careful, whether there is a pandemic or not. At that time, the lockdown was in effect and the only main difference I experienced was that the visitor schedule in the hospital was heavily regulated. I therefore took a flat screen TV with PlayStation and some dumbbells with me to the hospital to keep myself busy. After the transplantation it was easier to go outside, since it was very quiet on the streets and everyone kept their distance.
Since acute leukemia is life-threatening, unlike other less life-threatening diseases, they didn’t postpone my treatment and transplantation. Because of the pandemic, it did take a bit longer to transport the stem cells from my donor in Germany to the Netherlands.

You have beaten leukemia three times now. After so many times, how do you stay positive?
I think the most important thing is that I put everything in perspective. When I think of everything I have been through and the fact that I nearly faced death, every day that I am not ill is a good day. Nowadays, I only put effort in the things I like to do and invest in the persons I like to have around me. I enjoy life to the fullest. By eating a healthy diet and exercising regularly, I make sure my body is ready for any battle to come.

“I focused on the things I could control, and let go of what I couldn’t”

What would you say to someone who is  at the start of the fight against leukemia or another type of cancer?
It is hard to accept that you don’t have control over the way your body is dealing with the disease and whether your will survive or not. What helped me a lot was to focus on the things I could control, and let go of what I couldn’t control. For me this meant that good nutrition and exercise was more important than ever and I focused on gaining knowledge about the disease so that I could join the conversation and be involved in the decision-making process. Being in control over the things you can control also gives you peace. In case you would die, you would at least know that you did everything within your power.
Another thing that I would recommend is to focus on the people that you really care about. When you are diagnosed with leukemia or any other life-threatening disease, you get a lot of attention most of the time. Instead of investing in all these people, focus on the ones you rely on and care about the most.
It might also help to get in touch with fellow sufferers since they truly understand what you are going through.

Last question: were you able to play ice hockey on a professional level again?
The thing is that you have a higher chance on playing ice hockey on a professional level when you perform well in a junior hockey league between the age of 18-21. I was treated for leukemia at that time, therefore I have a slighter chance to get a contract in the US. Playing ice hockey in the first division of the Netherlands might be a possibility, however this is not the level I used to play so then it would be more like a hobby.
Therefore, I am focusing on other things at the moment. I get a lot of energy from motivational speaking and being an entrepreneur, working on healthy food products in cooperation with an American company. I just enjoy life to the fullest and focus on the things that make me happy!

Thank you Tom, for the inspirational story! It is really admirable how positive you are. We wish you all the best for the future!

Do you want to learn more about stem cell donation and how you can join the registry?
Click here for more information and registration.

The topic of this year’s Satellite symposium at the EFI virtual event was Improving transplantation success by NGS-based chimerism monitoring & genotyping beyond classical HLA genes. Many of you watched the prerecorded session and showed a lot of interest in our topics, thank you for that!

For those who have missed it, you can now watch the video here:

Program of Satellite symposium – Excellence in sharing:

• The role of MICA  and MICB in transplantation – Seiamak Bahram MD PhD, Professor of Medicine (Immunology)
• Clinical relevance of molecular markers in hemato-oncology – Lisette van de Corput PhD, Medical Immunologist at UMC Utrecht
• Chimerism monitoring by NGS: NGStrack & TKRengine – Pascal van der Weele PhD, Project Manager at GenDx
• New developments – Maarten Penning PhD, CTO GenDx

Chaired by Wietse Mulder PhD, CEO at GenDx

If you have any questions, feel free to reach us at marketing@gendx.com.

This week a collaboration agreement was signed between GenDx and the University Museum Utrecht (UMU). The financial contribution of GenDx will be used to realize the redesign of the museum.

— Persbericht ————————————————————————————-

Samenwerking GenDx en Universiteitsmuseum Utrecht

Het Universiteitsmuseum Utrecht (UMU) vormt sinds jaar en dag dé plek waar samenleving
en wetenschap elkaar ontmoeten. En met succes: de bezoekcijfers zijn de afgelopen jaren
flink gestegen, van 20.000 in 1996 naar 75.000 in 2019. Daar is het museumgebouw niet op
berekend. Na een grondige verbouwing is er bij heropening voldoende ruimte voor 100.000
bezoekers per jaar. Het UMU ontwikkelt zich van een wetenschapsmuseum tot een echt
onderzoeksmuseum. Volgens het principe van onderzoekend leren nemen we onze
bezoekers actief mee in het proces van wetenschap en laten ze deelnemen aan echt
onderzoek. Dankzij de steun van de Universiteit Utrecht kunnen we het museumgebouw
ingrijpend aanpassen.

Het herinrichten van het museum en het ontwikkelen van nieuwe presentaties doen we in
samenwerking met partners die het belang van onderzoek en wetenschapswijsheid
onderschrijven. De komende jaren zal GenDx, specialist in DNA-diagnostiek voor het
genetisch matchen van transplantatiepatiënten met donoren, een belangrijke financiële
bijdrage leveren aan deze herinrichting.

Wietse Mulder, CEO van GenDx: “de samenwerking met het UMU past ons goed. Wij weten
wat het betekent om als donor het verschil te maken. Het is daarom onze missie om de
kwaliteit van leven van transplantatiepatiënten wereldwijd te verbeteren. Dat vraagt veel
onderzoek. We vinden het essentieel dat het belang van onderzoek en wetenschap zichtbaar
is voor een breed publiek. Het UMU laat dat op innemende manier zien”.

“We zijn erg blij met de bijdrage van GenDx. Het brengt ons weer een stap dichterbij de
realisatie van onze droom”, aldus Paul Voogt, directeur van het UMU.

EFI 2021 will take place fully virtually from Wednesday, April 21 to Friday, April 23 and we are proud to be one of the Gold Sponsors. Make sure to visit our virtual booth and attend our activities in the comfort of your own home or office. You can find the detailed program with all activities here.

Virtual booth
Here, you can check our latest posters and product presentations, find online brochures, explore NGSengine by video, educate yourself by our prerecorded webinars, and chat with our application specialists and distributors.

Satellite Symposium
Don’t forget to participate in this year’s edition! You can watch the prerecorded session on demand. The topic is Improving transplantation success by NGS-based chimerism monitoring & genotyping beyond classical HLA genes. If you have any questions, you can reach us via the chat or meeting corner in our booth.

Tulip Run
Last but not least, participate in the virtual edition of the Tulip Run. Find your own perfect 5 km running route in your city and run it during one of the EFI conference days. Register now and don’t forget to share your picture with us!

We look forward to e-meeting you!

UTRECHT – Van 2 maart tot 22 maart heeft GenDx, een bedrijf in de moleculaire transplantatiediagnostiek, haar medewerkers uitgedaagd om in beweging te komen voor het Prinses Máxima Centrum en Stichting Leergeld Utrecht. Ruim voor de deadline was het maximaal te behalen bedrag van €5.050 al verzameld door circa 40 sportieve medewerkers. Op woensdag 31 maart jl. zijn de cheques van €2.525,-  per doel overhandigd.

De doelstelling van GenDx Charity Challenge is bijdragen aan de fysieke en mentale gezondheid van medewerkers van GenDx in een periode waar – gedeeltelijk – thuiswerken, sluiting van sportscholen en -verenigingen, en minder sociale contacten het leven beïnvloeden. Deze activiteit sluit perfect aan bij de waarde van GenDx om te delen, hetgeen we ook binnen het werkveld van transplantatie diagnostiek van groot belang achten.

GenDx, gelegen op het Utrecht Science Park, is als spin-off van UMC Utrecht een van origine Utrechtse onderneming.  Wij zijn trots op ‘onze afkomst’ en steunen daarom verschillende lokale organisaties, waaronder Stadsschouwburg Utrecht, sportverenigingen Histos, Triton, Orca en SPIN en zeer recent het Universiteitsmuseum Utrecht. Voorafgaand aan de start van GenDx Charity Challenge kregen onze medewerkers de kans om een goed doel te kiezen uit een lijst van zowel lokale als internationale initiatieven, met als resultaat de keuze voor het Prinses Máxima Centrum en Stichting Leergeld Utrecht.

Beide organisaties willen het gedoneerde bedrag gebruiken om kinderen te laten bewegen. Stichting Leergeld Utrecht zet het bedrag in voor een specifiek project om kinderen uit lage-inkomens gezinnen te ondersteunen met hun contributie voor sportclubs. Binnen het Prinses Máxima Centrum wordt de donatie gebruikt voor de afdeling Quality of Life. Hieronder valt ook het Maximaal Bewegen project, dit programma richt zich op een sneller en beter herstel van kinderen met kanker door voldoende beweging en een verlaging van de stress bij kinderen en ouders tijdens het behandelproces door afleiding en sporten.

Overhandiging cheques op woensdag 31 maart 2021. Foto boven: Roelien Brommersma (GenDx) en Harmen van de Kamp (Stichting Leergeld Utrecht), Foto onder: Nienke Beek (Prinses Máxima Centrum) en Manon de Jong (GenDx)

Download Persbericht

In a few weeks, the EFI conference will start. Unfortunately no in-person event in the vibrant Scottish city of Glasgow, but online attendance in the comfort of your own home or office.
Since it became a tradition at EFI conferences, we can not let the conference pass without the Tulip Run. Therefore we invite you to participate in a virtual edition of the Tulip Run!

How?
In Glasgow, we planned a beautiful running route starting at the conference venue, along the Clyde River to the Riverside Museum and back. With a distance of 5 km, the perfect run to start the second conference day. Curious about the Glasgow route? Watch the video and virtually explore the route including all highlights:

With this in mind, we like to challenge you to find your own perfect 5 km running route in your city and run it during one of the EFI conference days. Of course you can’t run without a proper running shirt, all participants therefore receive a Tulip Running shirt at their home- or office address.

Ready to run with us? Register now!

We are proud to share that we have completed IVD registration in Canada for our HLA typing products NGSgo®-AmpX v2 and NGSgo®-MX6-1.

Our CEO Wietse Mulder commented: “We have worked intensely to validate and document these NGSgo products according to the Health Canada IVD regulation. It took a great deal of work to complete, and we are proud to be the first supplier that can offer this IVD product for the transplant community in Canada. We believe the products will truly support better typing of the HLA genes.”

Press release GenDx IVD registration Health Canada

Our mission is to improve the quality of life and survival of transplant patients worldwide. With a team of over 60 passionate employees, we are committed to develop innovative products and actively support charities and institutions that share our mission.
It is therefore with pride that we support the Transplantoux event of the Give & Live Cycling Club. We are honored that our colleagues Henk van Laar and Stefan Timmerman have the opportunity to climb the Mont Ventoux together with a group of fit transplant patients and donors.

More information about the Transplantoux and Give&Live Cycling Club: https://giveandlive.nl/ 

We are proud to introduce you to our new colleagues in the Software-, Production- and US Sales team: Jochem Boeter, Carlijn Ruijter, Remi Jansen, Véra Spiekman, Bart Valkenburg and Andres Rondon.

We wish you all the best in your new job and are happy that you have joined GenDx!

Have you heard about PIRCHE?

Register now for our webinar on February 16:

PIRCHE Epitope Matching in Kidney Transplantation: A Case Study

PIRCHE® is a new technology for estimating the risk of immune responses after transplantation. It is the first HLA matching algorithm taking into account the indirect pathway of allo-recognition. PIRCHE currently has more than 650 users in 57 countries.

The input of the algorithm is the HLA genotype of a sample. The output of this algorithm is a score (number), to be considered when searching for a donor.

With NGSengine version 2.16 or higher, you can have access to the PIRCHE export feature. GenDx customers can also receive full access to the full range of PIRCHE epitope matching modules through the PIRCHE web platform. You only need to register selecting GenDx as preferred partner.

For more details, visit www.pirche.com

GenDx is a proud sponsor of the AFDN (Allele Frequency Net Database) website. AFND is a very useful tool for researchers as they can search population frequencies of several immune genes such as Human Leukocyte Antigens (HLA), Killer-cell Immunoglobulin-like Receptors (KIR), Major histocompatibility complex class I chain-related (MIC) genes, and a number of cytokine gene polymorphisms. It contains information at allele, haplotype and genotype level depending on the polymorphism. Users can now find on the website data from more than 2000 populations on 7 million individuals.

AFND is currently maintained by researchers at Royal Liverpool University Hospital and the University of Liverpool, in collaboration with other international scientific groups.

We proudly announce that earlier this year we have appointed Professor Seiamak Bahram as scientific advisor to our company. Professor Bahram has an extensive knowledge of the Major Histocompatibility Complex (MHC) and in particular the MHC Class I chain-related molecules A (MICA) and B (MICB). His scientific advice will provide valuable input to the company regarding relevant immunological targets and the use of diagnostic assays in a hospital setting.

Press Release Appoinment Prof. Seiamak Bahram.

The NGSgo® Workflow has now been visualized! We have recorded the protocol steps of the NGSgo® Workflow in 9 separate videos.. In these videos, our colleagues Jannetje Kooij B.ASc, Remco Malestein B.ASc and Robert Welleweerd B.ASc show you how to execute each step of the workflow. The videos can be used as an addition, not as a replacement, to the available Instructions for Use.

All videos are now available on our website: www.gendx.com/gendx_education/instructional-videos-ngsgoworkflow/

The multiplex you have been waiting for!

Amplification primers for eleven loci are multiplexed in three tubes. The three-tube design results in lower noise levels, better-balanced alleles, and higher quality compared to a one-tube approach. This means more reliable typing results.

From DNA to results in only 1,5 days!

Start your amplification on day 1 and have your typing report on day 2 before noon. You can run 16 samples on an Illumina micro flow cell.

Read the press release about the new NGSgo-MX11-3, check out the product information page or read our blog, and try out our new multiplex now!

2020 is a milestone year for both GenDx and student rowing club Orca. While GenDx celebrates its 15^th anniversary this year, Orca will reach its 50^th anniversary in October, a huge accomplishment for both.

GenDx CEO Wietse Mulder has been a member of Orca from 1983 to 1996, participating in several rowing races with his Orca team ‘Dé clubacht’. Several other Orca teams were competing at the same time, and there was always some rivalry over which team would get to use the best 8⁺ boat. As Wietse and his team did not always win the boat struggle, they jokingly said that one day they would buy their own boat.

In the milestone year 2020, Wietse decided to buy the boat for Orca, and on Saturday, August 22, Wietse baptized the brand new 8⁺ Filippi boat in the presence of current Orca members, as well as his former team members. During the ceremony, Wietse elaborated on his reasoning to support the club and referred to two of his main entrepreneurial strategy principles: ‘Dare to share’ and ’Do not always expect a return of investment’.

After the ceremony, pictures were taken of the boat and the (former) Orca members, taking the COVID-19 restrictions into account. The pictures show the beautiful boat with special GenDx graphics, designed by Leon Hulst from WAT Ontwerpers.

We have released the new version of our NGSengine software, including the IMGT/HLA database release 3.40.0. For a complete overview of all new updates, please download the release certificate using the link below.

Make sure to update your software to the latest version to have access to the new database.

Download Software update

Download Release certificate

The summer is in full swing! While some are enjoying a well-deserved summer break, others have already enjoyed their holiday and are now keeping the office running.
After a short break in July and August, we will start again with the webinars in September. On September 2 we will kick off with the webinar “New features of NGSengine”, followed by the webinar Towards defining the immunogenicity of HLA eplets on September 16.

Attend the webinar and receive 0.15 continuing education credits (CECs).

Stay up-to-date on all our educational events by frequently checking our website: GenDx.com/education. If you have any questions, please contact us directly via education@gendx.com

We have released the new version of our SBTengine software.  SBTengine 3.27.0 includes the latest IMGT/HLA database 3.40.0.

Make sure to update your software to the latest version to have access to the new database.

Download Software update

Download Release certificate

Last week, Wietse Mulder PhD (CEO, GenDx) and Joost Kook (Deputy Director, Stadsschouwburg Utrecht) have signed a new contract for three years to confirm mutual engagement and strengthen their cooperation. Three years ago, GenDx became partner of the Stadsschouwburg Foundation. In the new contract GenDx becomes a founder.

Please find the full press release in Dutch below:

GenDx en Stadsschouwburg verstevigen samenwerking

Afgelopen week ondertekenden Wietse Mulder (PhD, CEO van GenDx) en Joost Kok (adjunct-directeur Stadsschouwburg Utrecht) een nieuwe overeenkomst voor drie jaar om de wederzijdse betrokkenheid te bevestigen en de samenwerking te verstevigen. Drie jaar geleden trad GenDx toe als partner van de Stadsschouwburg Foundation. In het nieuwe contract wordt GenDx founder.
De Stadsschouwburg Foundation is een alliantie van Utrechtse organisaties en bedrijven die de schouwburg in staat stellen jaarlijks een aantal exclusieve (en kostbare) producties in het programma op te nemen. Als waardering voor hun steun biedt de schouwburg deelnemers aan de foundation bijzondere faciliteiten zoals ontvangsten van relaties, ontmoetingen tussen founders en diverse vormen van exposure. Andere Founders zijn Douwe Egberts, Rabobank Utrecht e.o. en de Provincie Utrecht.

Wietse Mulder (PhD, CEO van GenDx):
“Drie jaar geleden zijn we partner geworden van de Stadsschouwburg, met het volgende statement: ‘Wij weten wat het betekent om als donor het verschil te maken. Daarom is GenDx partner van Stadschouwburg Utrecht.’
GenDx is een Utrechtse Life Science onderneming en gevestigd op het Utrecht Science Park. In een tijd waarin nagenoeg geen voorstellingen kunnen worden gegeven bij de Stadsschouwburg, willen wij onze betrokkenheid versterken door founder te worden.
De relatie met de stadsschouwburg ligt ons na aan het hart en wordt door onze medewerkers zeer gewaardeerd. Zij kijken er naar uit om weer een voorstelling van eigen keuze bij te kunnen wonen. Daarnaast zijn we een tevreden bezoeker van restaurant Zindering, waar we regelmatig met onze gasten naar toe gaan.”

Joost Kok (adjunct-directeur Stadsschouwburg Utrecht):
“De Stadsschouwburg Foundation is een fijne plek waar veel Utrechtse bedrijven zich thuis voelen. De founders en partners steunen al jaren de activiteiten van Stadsschouwburg Utrecht. Zeker in deze tijd is deze steun hard nodig. We investeren veel in relatiebeheer waarbij het persoonlijke contact voorop staat. Dat dit werkt zien we aan een trouwe partner als GenDx, die nu besloten heeft om founder te worden. Het is hartverwarmend om te zien dat Gendx zoveel vertrouwen in ons uitspreekt, voor nu en in de toekomst.”

Foto: V.l.n.r.: Joost Kok (adjunct-directeur Stadsschouwburg Utrecht), Wietse Mulder (PhD, CEO GenDx) en Dennis Dercksen (manager sales & sponsoring Stadsschouwburg Utrecht)

The Tulip Challenge was initiated during the COVID lockdown period to encourage people to stay fit, be connected with the HLA family and united by the common goal: to enhance the outcome of transplantation.

Last May, 87 participants from 14 different countries have completed the Tulip Challenge. Thank you for sharing your photos and videos of unique, impressive and exhausting workouts, which will definitely inspire all of us for the future.

Together, we have raised €2175 which will be donated to the organizers of the 18th International HLA & Immunogenetics Workshop to support research on COVID-19. Next week, the cheque will be handed over to the chairmen Eric Spierings and Sebastiaan Heidt.

We have come to the end of the Tulip Challenge in May 2020. Thank you all for joining and sharing your workout with us! We are glad that the Tulip Challenge kept us connected with the HLA family during these extraordinary times and that we are united by the common goal: to enhance the outcome of transplantation.

Thanks to 87 completed Tulip Challenge in 14 different countries, we will donate € 2175 to the organizers of the 18th International HLA & Immunogenetics Workshop to support research on COVID-19.
You can check our photo gallery to see all Tulip Challenge workouts that were done by you: gendx.com/2020/05/tulip-challenge-2020/ 

We cooperate closely with our distributors, who also contribute to education and offer services to HLA labs in over 60 countries. During these challenging months, we use the webinar opportunities to keep contact, educate and discuss the ongoing support in the HLA field. Besides discussing our latest product updates, we finished this time with a small ceremony to award 3 distributors who have excelled in the last year in their respective markets, resp. Voden Medical from Italy, Jasika from Croatia and Pensabio from Brazil. Congratulations!

Dear customers,

We follow the developing outbreak of COVID-19 closely by monitoring the World Health Organization (WHO) and the Dutch government including the health measures of National Institute for Public Health and the Environment (RIVM) in the Netherlands. In general, we have defined and safeguarded our critical functions where possible and actively minimized physical contacts in our company, e.g. by increasing online cooperation and working in shifts.

The following is important for you to know:

• Both our Dutch head office and US office are open as usual. You can contact us via our general email address and phone number(s): info@gendx.com and +31 (0)30 252 3799  or +1 (312) 815 5006
• Our support team remains available for all your questions. Our intention is to answer your questions within 24 hours.
• We have secured the safety and quality of our products by working in shifts to continue production and logistics.
• Orders continue to be processed and shipped. Please place your order via order@gendx.com  or your local distributor.
• All physical contact events in the upcoming month are canceled. We will organize some additional webinars instead, e.g. on April 8th the webinar  Multiplex amplification for fast and easy HLA typing is scheduled – click here for more information and registration

Even during this difficult time, we are happy to assist you and we hope that the potential damage for all our customers may be limited. Please take care of yourself and others, and stay healthy.

Kind regards,

The GenDx Team

To commemorate our 15th anniversary, we are sharing a series of webinars this year! In the coming weeks we will offer multiple webinars, each taking approximately 30 minutes.

Register for one or multiple webinars via the link(s) below.

Are you up for a workout challenge?

As an alternative to the well-known Tulip Run, the sports highlight of the EFI meetings, we invite you to join the Tulip Challenge in May 2020. This challenge can be completed from any city, country and continent in the world and goes beyond running since some preventive measures restrict people to go outside.

Share the workout that keeps you healthy and stay connected with the HLA field, as we used to do with the Tulip Run.

Are you in?

5 Steps to participate in the Tulip Challenge

• Register before May 15 via: tulip-challenge-2020.eventbrite.co.uk and wait for your welcome package to arrive at your home.*
• Use the textile marker to write down your city or country on the front of the T-shirt. We also include a card to write down your workout.
• Run, walk, plank, squat or do another (indoor) workout in May, wearing your special edition Tulip Challenge T-shirt and make a photo or video.
• Send the photo or video to marketing@gendx.com or share via your social media channel using #tulipchallenge2020. We will publish and/or share your workout on our social media channels to inspire others in the HLA field all around the world to do your workout as well.
• For every submission, GenDx will donate €25,- to the organizers of the 18^th International HLA & Immunogenetics Workshop to support research on COVID-19.

*We have a limited amount of Sports T-shirts available. Register soon to receive this special edition Tulip Challenge Sports T-shirt.

With this challenge we hope you will be encouraged to stay active and fit to overcome this exceptional period, be connected with the HLA family and united by the common goal: to enhance the outcome of transplantation.

GenDx is proudly introducing the renewed Custom Lab Service. Empowered by our unsurpassed HLA expertise and advanced high-quality systems, we are fully committed to providing HLA typing services to facilitate HLA research.

Are you a CRO, CDMO, Pharma or a research organization and in need for support of your HLA typing project? You can just send us the DNA you would like to analyze and GenDx will report back the tissue typing results. Turnaround time and follow-up depends on the request.

For more information on our Custom Lab  Service, click here or contact us.

A new decade has started. And, 2020 is a remarkable year as GenDx celebrates its 15th anniversary! ‘Excellence in sharing’ is our theme for 2020. One of the values of GenDx which will get a lot of attention by offering you interesting topics and in depth information related to the HLA field. Keep an eye on our event calendar for webinars and educational events. Visit us during the main congresses or just contact our team to learn more about our continuously expanding product portfolio. We are happy to share our successes with you!

This week we have released a software update for KMRengine, version 2.3 is now available.

Make sure to update your software to the latest version to enjoy the new features! For a complete overview of all the new features of KMRengine 2.3, check the release certificate and upgrade to KMRengine 2.3 (you need to register or login to view or download these files).

We are happy to announce that GenDx has registered NGSgo®-AmpX v2 and NGSgo®-MX6-1 as CE-marked IVD.

The NGSgo®-AmpX v2 and NGSgo®-MX6-1 primer kits are intended for the amplification of both HLA alleles present in a sample for downstream sequencing applications. They are intended for in vitro diagnostic use by professional users in diagnostic laboratories, such as laboratory technicians and physicians, trained in HLA-typing and DNA sequencing.

Customers that are interested in implementing these products to their workflow and wonder whether they could benefit from this registration, can receive more information by contacting their local GenDx distributor or by contacting GenDx directly.

Genome Diagnostics B.V. (“GenDx”) announced today that they have entered a collaboration with the Berlin-based company PIRCHE AG and have released a new version of their software NGSengine®. NGSengine, globally considered to be the ultimate Human Leukocyte Antigen (HLA) typing software for multiple NGS platforms, can now export HLA typing results of an individual sample directly to the PIRCHE matching services website. This will facilitate laboratories to predict indirectly recognizable HLA epitopes for either hematopoietic stem cells or solid organs.

About the PIRCHE algorithm
HLA mismatches between donors and recipients may lead to alloreactivity after transplantation. With the identification of numerous new HLA alleles, the risk of alloreactive responses towards HLA mismatches after transplantation has become more challenging to predict. The PIRCHE (Predicted Indirectly ReCognizable HLA Epitopes) algorithm has been developed to estimate the risk associated to alloreactive T-cell responses. The PIRCHE algorithm addresses the indirect recognition of HLA mismatches. It aims to improve transplant outcome by reducing Graft-versus-Host Disease and by enhancing Graf-versus-Leukemia effects after hematopoietic stem cell transplantation and cord blood transplantation. In the field of organ transplantation, the algorithm allows estimating the incidence of developing donor-specific antibodies against the transplant, which is considered the major risk of graft failure.

About High-Resolution HLA Typing
The HLA system consists of a large family of highly variable genes and allelic variants which form the basis of the human immunological defense system. In stem cell transplantation, matching patient and donor is vital as small differences between HLA alleles may have serious effects on the outcome of transplantation. High-resolution typing is a technology which enables determination of variations in nucleotides, making it ideal for stem cell transplantation purposes.
GenDx offers the NGSgo® reagent line and the NGSengine software package for NGS-based HLA typing.