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Transition of the AlleleSEQR® products from Celera to GenDx

Dear Sir, Madam,

Welcome to GenDx!

Thank you for your interest in our company. We have been looking forward to start working with you in the challenging field of HLA sequencing and chimerism monitoring. Through the acquisition of Celera products we believe that a significant larger part of the world-wide tissue typing community can be served.

Our main objective is to keep confidence that GenDx can be your partner to enable high resolution HLA typing. Hopefully you have received already all information and answers regarding the GenDx AlleleSEQR HLA and chimerism products to continue your activities. An overview of recent communications can be found on this webpage or contact us at support@gendx.com or +31 30 252 3799.

Our team is eager to start working with you, to understand your needs and expectations!

Kind regards,

Wietse Mulder, PhD
Managing Director

Declaration of Equivalence AlleleSEQR HLA

The performance of AlleleSEQR-HLA products manufactured at the production facility of GenDx in The Netherlands are equivalent to the AlleleSEQR-HLA products manufactured by Celera Corporation in the USA. Feel free to download the Declaration of Equivalence.

Download Declaration of Equivalence AlleleSEQR HLA

Request for validation AlleleSEQR HLA

In case you would like to perform a validation yourself, we can support you in
this process. We propose validating 10-25 samples being sufficient to
demonstrate equivalence.

Request form for AlleleSEQR HLA validation

AlleleSEQR HLA validation report

If you would like to receive an AlleleSEQR HLA validation report just fill in the contact form.

Contact form for AlleleSEQR HLA validation report

Transition updates

Updates about the transition of AlleleSEQR products from Celera to GenDx, up to now distributed by Abbott Molecular.

Factsheet version M015-051


GenDx AlleleSEQR Transition Update Sept 2015


GenDx AlleleSEQR Transition Update Aug 2015

 

 
GenDx AlleleSEQR Transition Update July 2015

Transition

Why has GenDx decided to buy the AlleleSEQR products from Celera?

We believe that the acquisition of the Celera HLA asset underlines the position of GenDx as being a team of HLA sequencing experts and shows our commitment to the transplantation community that we will offer the best tools, services and education enabling excellent HLA typing, facilitating better matching and giving hope on better outcome of transplantations

GenDx believes that by the acquisition of the Celera HLA assets GenDx can serve a much larger part of the world-wide tissue typing community. GenDx can provide them the best tools, support and education on sequencing based HLA typing and chimerism testing, already now with the Sanger based strategies and as soon as customers are ready to change, with Next Generation Sequencing strategies.

In recent years GenDx has invested heavily in the latter. Last year, complete workflows for the Illumina Miseq and Ion Torrent PGM system were released, as well as a robust amplification strategy for the PacBio RSII sequencer. Last year GenDx received CE marking for the NGSgo-AmpX product line, being the first company offering IVD components for NGS-HLA typing.

 

Who will manage the transition?

The whole GenDx team is involved and motivated to swiftly execute this project. The two persons managing all aspects of this transition are Sanne Vendelbosch and Maarten Penning. They will be your first point of contact for all issues you would like to discuss. They can be reached via: info@gendx.com or by calling us on +31 30 25 23 799 (Europe) or by using skype alleleSEQR-gendx-

 

From the US, you can also contact Chelsea Hines of GenDX Products Inc, via +1 240 841 5723.

 

When will the transfer take effect?

GenDx will start taking orders as of January 1st, 2016. However, well before that time, we will work with you, e.g. to provide you with materials that you need to do your validations.

 

What will happen now?

It is our intention to contact you in the coming weeks to discuss how we can help you to ensure a smooth transfer. We would like to work with you to understand any concerns you might have and to provide you with an answer to any question you might have. We invite you to share with us all your concerns and requests as well as any information/documentation you might need from us. Also, we would like to understand details of any agreements that you have concerning the AlleleSEQR HLA typing and chimerism products.

 

In the coming weeks, we will share with you how we are planning to handle this transition and what you can expect of us in the short as well as in the long run. During this process we will keep you up-to-date about any the progress.

 

In the meantime, we are producing AlleleSEQR HLA typing and chimerism kits. First kits produced are intended to be used for internal validation studies and to demonstrate equivalence to the AlleleSEQR kits produced by Celera. Later this year, we will be able to provide you with AlleleSEQR kits produced by GenDx to perform your validation studies. It is helpful for us, if you could let us know what would be needed to perform your validations as soon as possible, so that we can consider your needs in our production planning.

Ordering, pricing & Delivery

When can I start ordering products from GenDx?

All orders to be shipped in 2016 can be send to GenDx.
GenDx started shipping AlleleSEQR products on Monday 4th January 2016.

GenDx Product Catalog

 

How and where should I place an order?

In certain countries, GenDx has appointed local distributors. The list of countries and details of the distributors can be found at: http://www.gendx.com/company/distributors. For all other countries orders can be placed by sending an email to order@gendx.com.

 

How will this transfer affect the price of the AlleleSEQR products?

It is our aim to provide you with the products under the same conditions as you are used to. It is our intention to respect the agreements as much as possible that you have with regard to pricing, discounts etc. Therefore we, or our local distributors, will contact you in the coming weeks to discuss price agreements and to discuss with you how we can help you to assure a smooth transfer. Most of the required information will be provided by Abbott Molecular. But you may help us as well by sending a copy of the agreement to sales@gendx.com

 

Will the transfer have any effect on pricing of SBTengine? (Our lab gets SBTengine for free from Abbott, will this change?)

We at GenDx believe that SBTengine, our HLA typing software for Sanger SBT, represents a lot of value for accurate HLA typing. Therefore our policy is that customers should pay for use of this software. Abbott is now paying for each software licence that we provide to you. If you get SBTengine for free from Abbott, it is highly likely that the price for the software is included in the price you pay for the reagents. As it is our intention to respect any agreements that you have regarding pricing as much as possible, discounts etc, we would like to understand the current agreements that you have and work with you to provide you with an attractive offer.

 

How will this transfer affect ongoing tenders?

It is our intention to respect all agreements that currently exist as much as possible. At this moment we are working with Abbott and Celera to make an inventory of the details of all ongoing tenders. In the coming weeks we will contact you to discuss all necessary details with you.

 

What will happen to the (price) agreements that we have with Abbott?

It is our aim to provide you with the products under the same conditions as you are used to. It is our intention to respect the agreements that you have with regard to pricing, discounts etc. as much as possible. Therefore we, or our local distributors, will contact you in the coming weeks to discuss price agreements for 2016 onwards and to discuss how we can help you to assure a smooth transfer. 

AlleleSEQR HLA typing products

How will this transfer affect the AlleleSEQR products?

GenDx does receive all protocols for manufacturing and executing QC’s and will make sure that the product will have the same formulation and equivalent performance as compared to the products as you have used them before. We will also strive to keep the look-and-feel of the similar to what you are used to as much as possible.

 

How will this transfer affect the performance of the AlleleSEQR products?

The performance of the products produced by GenDx will be at least equivalent as compared to the products that were produced by Celera. We can guarantee this, because of our long lasting experience with the production of comparable products in our ISO 13485 certified production facility. To convince yourself that the products have equivalent performance, you can have a first glance on some initial results in the picture below.

 

Fig. 1. HLA-C exon 2 forward sequencing primer.

Upper part: Celera AlleleSEQR amplification and sequencing primer, lower part: GenDx AlleleSEQR amplification and sequencing primer.

 

 

How will this transfer affect the format/formulation of the AlleleSEQR products?

It is our intention to provide you with the identical formulation of the products. This means that the product will have the same number of tubes, the same number of reactions per kit. It is even our intention to maintain the look-and-feel of the product as much as possible.

 

What kind of improvements can I expect?

We are considering implementing a number of improvements to the current AlleleSEQR products, for example:

  • Extend the SBT HLA typing products with additional loci: HLA-DQA1, HLA-DPA1, HLA-DRB3/4/5
  • Extend the analysis region, such that you will have full exon coverage of all class I genes, and full exon 2 and 3 coverage of the class II genes.
  • Provide you with a more extensive set of Group Specific Sequencing Primers to solve the most ambiguities and to reach the highest possible resolution.
  • Offer a more flexible alternative for the AlleleSEQR Chimerism Screening product.

AlleleSEQR Chimerism products

How will this transfer affect the AlleleSEQR products?

For most of the products, GenDx will make sure that the product will have the same formulation and equivalent performance as compared to the products as you have used them before. We will also strive to keep the look-and-feel of the product as much as possible similar to what you are used to.

 

One exception will be that we are not planning to produce the Chimerism Screening Plate Pack. We are considering to still make the individual Quant Assays available, so for any patient that is currently under surveillance, you can continue to do so with the identical markers. For the screening of new patients, we are confident that we can provide you with an interesting alternative. For more information, you can contact us directly.

 

How will this transfer affect the performance of the AlleleSEQR products?

The performance of the products produced by GenDx will be at least equivalent as compared to the products that were produced by Celera. We can guarantee this, because of our long lasting experience with the production of comparable products in our ISO 13485 certified production facility.

 

How will this transfer affect the format/formulation of the AlleleSEQR products?

For most of the products, it is our intention to provide you with the identical formulation of the products. This means that the product will have the same number of tubes, the same number of reactions per kit. It is even our intention to maintain the look-and-feel of the product as much as possible.

 

One exception will be that we are not planning to produce the Chimerism Screening Plate Pack. We are considering to still make the individual Quant Assays available, so for any patient that is currently under surveillance, you can continue to do so with the identical markers. For the screening of new patients, we are confident that we can provide you with an interesting alternative. For more information, you can visit: http://www.gendx.com/products/kimerdx or contact us directly.

SBTengine

Will the transfer have any effect on pricing of SBTengine? (Our lab gets SBTengine for free from Abbott, will this change?)

We at GenDx believe that SBTengine, our HLA typing software for Sanger SBT, represents a lot of value for accurate HLA typing. Therefore our policy is that customers should pay for use of this software. Abbott is now paying for each software licence that we provide to you. If you get SBTengine for free from Abbott, it is highly likely that the price for the software is included in the price you pay for the reagents. As it is our intention to respect any agreements that you have regarding pricing as much as possible, discounts etc, we would like to understand the current agreements that you have and work with you to provide you with an attractive offer.

 

Contact

Who can I contact if I have more questions or would like to speak to someone about this transition?

Our transition managers, Sanne Vendelbosch and Maarten Penning are happy to discuss your questions or to speak to you about the transition. They can be reached via: info@gendx.com or by calling us on +31 30 25 23 799 (Europe) or by using skype alleleSEQR-gendx-

From the US, you can also contact Chelsea Hines of GenDX Products Inc, via +1 240 841 5723.

end faq

 
 

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