Companion Diagnostics
CDx solutions with GenDx: Your partner from start to finish
GenDx as a strong CDx partner
Precision medicine is accelerating, but matching the right patient to the right therapy remains a key bottleneck. Companion diagnostics (CDx) are critical to this, yet co-development introduces scientific, operational, and regulatory challenges. Addressing these early is essential to successful CDx–drug co-approval. At GenDx, we help partners navigate CDx co-development alongside the development of new precision medicine therapies.
We bring a strong track record in transplantation diagnostics, with a unique strength in resolving regions that require specialized assay design and bioinformatics to accurately resolve. Our current flexible assay design and scalable NGS workflows target HLA and related genes (e.g., KIR, MICA, MICB), genes that are increasingly being investigated for their potential in (HLA-restricted) immunotherapies in clinical trials. For example, these approaches are particularly relevant in the development of TCR-based and other HLA-restricted therapies in oncology. Building on our track record in transplantation diagnostics, we develop and offer assays primarily enabling high-resolution germline immunogenomic profiling, with potential integration into broader tumor profiling workflows.
At GenDx, we integrate key capabilities in-house, from R&D to Regulatory Affairs, supporting an efficient and well-coordinated development process from idea to registered IVD. Additionally, GenDx has a global network of channel and service partners. This positions GenDx as a strong partner for companion diagnostic development, enabling partners across the CDx development pathway to drug–diagnostic co-approval, with a focus on accelerating timelines and de-risking biomarker strategies and regulatory execution. We can be your partner from biomarker research (RUO) to IVD development and regulatory submission, enabling patient access to CDx testing and matching of patients to an effective therapy. Our solutions span RUO, IUO and IVD applications, with CDx development aligned to regulatory requirements for therapeutic pairing.
Efficient and easy-to-use NGS-based solutions
In 2014, GenDx launched its first NGS-based HLA typing solutions, designed for high-resolution characterization of individual samples and scalable workflows. This portfolio has been continuously expanded and refined. Our portfolio includes, but is not limited to, amplification solutions for Class I and II HLA genes, non-classical HLA genes and other genetically complex immune-related genes, including KIR, MICA and MICB, available as both singleplex and multiplex solutions (Not all products are CE marked, availability of products in each country depends on local regulatory market authorization status).
Along with the amplification solutions, GenDx offers proprietary library preparation workflows, known for their ease-of-use and efficiency. Additionally, our proprietary HLA analysis software, NGSengine®, is a widely adopted solution for NGS-based typing of polymorphic genes. NGSengine® supports high analytical accuracy and reproducibility through validated workflows and robust allele-calling algorithms. Our assay and NGS workflow design facilitate the development of fit-for-purpose assays.
The increasing recognition that immune-related genetic variation may play an important role in response to immunotherapies and the emergence of HLA-restricted therapies (also see one of previous blog posts), create demand for robust, high-resolution genotyping solutions. Our experience in high-resolution genotyping enables allele-level resolution of immunogenomic variation to support biomarker research and exploratory patient stratification in immuno-oncology. Our diagnostic solutions combine flexible assay design, scalable multiplex workflows, and robust analysis software to enable consistent and reproducible performance.
Demonstrated expertise as IVD manufacturer, compliant with IVDR
GenDx has a clear track record in the IVD field, supported by an ISO 13485-certified quality management system and IVDR-compliant development and manufacturing processes. In May 2022, GenDx became the first company in the field of transplantation diagnostics to attain IVDR certification for both their HLA typing reagents and associated analysis software. We facilitate your CDx development program, enabling progression from biomarker discovery to commercialization.
Building on our heritage in the transplantation field, GenDx has meticulously maintained high quality and adhered to regulatory standards for the development and manufacture of its IVD solutions. Our focus on quality ensures reliable performance of our IVD solutions in clinical settings.
Why partner with GenDx
At GenDx, we recognize the challenges a CDx co-development program in parallel to the development of new precision medicine therapies poses. Challenges arising both in terms of resources needed for validation and expertise needed for navigating the complex regulatory landscape. In our experience, the most effective solutions are driven forward and accelerated by collaborations and partnerships. As such, GenDx has a global network of channel and service partners, enabling CDx co-development through analytical validation, clinical performance study design, and regulatory strategy alignment in collaboration with pharmaceutical partners. This includes biomarker strategies for emerging HLA-restricted and TCR-based therapeutic modalities.
Our existing NGS workflows, which allow for the development of fit-for-purpose assays, together with our demonstrated experience with IVDR, make us your knowledgeable and reliable partner. We de-risk the development of your CDx, organize the clinical performance studies, and register new CDx products.
How we accelerate CDx programs:
- Streamline development from exploratory biomarker research to IVD registration through integrated R&D and regulatory capabilities
- Reduce assay development timelines and technical risk with pre-validated workflows
- De-risk biomarker selection, assay performance, and downstream clinical validation, using early feasibility assessment and assay design optimization
- Enable efficient regulatory strategy and submission based on our experience with IVDR
- Continuity from early research (RUO) through clinical development to commercialization
Our services
At GenDx, rooted in the background of transplant diagnostics, we believe that through the power of sharing and collaboration, the patient will benefit the most. We provide tailor-made CDx services and solutions, specifically aligned with the needs of your therapeutic strategy.
Among others, our solutions include:
Interested in what we can offer? Check our portfolio
Our portfolio includes:
- Next-Generation Sequencing (NGS) –long- and short-read, PCR-based or capture-based enrichment, single locus or multiplex, library preparation, and analysis software compatible with multiple sequencing platforms
- Proprietary analysis software – widely adopted solutions for the analysis of NGS-based typing of HLA and related genes and chimerism monitoring, providing high analytical accuracy and reproducibility through validated analysis pipelines
- qPCR and dPCR – cfDNA (cell free DNA) and gDNA (genomic DNA) analysis & software
- Sanger Sequencing – Reagents and analysis software for high-resolution Sanger sequencing-based HLA typing
Want to know more? Contact us!
Are you unsure about your diagnostic approach or navigating CDx development and regulatory requirements? Read more on our dedicated Companion Diagnostics webpage and do not hesitate to contact us! The GenDx CDx team would be pleased to schedule a meeting and discuss your request in more detail.
