Companion Diagnostics

Precision medicine is accelerating and matching the right patient to the right therapy remains a key bottleneck. Companion diagnostics (CDx) are critical to this, yet co-development introduces scientific, , and regulatory challenges. Addressing these aspects early is essential to successful CDx–drug co-approval. At GenDx, we recognize the challenges a CDx co-development program may pose, both in resources and in expertise. We help partners navigate CDx co-development alongside the development of new precision medicine therapies.  

Why partner with us for CDx Development?

• Proven HLA expertise built on decades of transplantation diagnostics experience.
• Advanced assay development for complex genomic regions requiring specialized assay design and bioinformatics.
• Comprehensive immunogenomic profiling across HLA, KIR, MICA, MICB, and other clinically relevant immune genes.
• Flexible technology platforms spanning NGS, qPCR, dPCR, and Sanger sequencing.
• Validated software and analysis pipelines delivering high analytical accuracy and reproducibility.

Explore our CDx technology portfolio to discover the immunogenomics technologies, assays, and bioinformatics capabilities that support biomarker research, translational studies, and companion diagnostic development.

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 :

At GenDx, we provide integrated CDx development services spanning assay development, bioinformatics, regulatory strategy, clinical performance studies, and IVD registration. By supporting programs from RUO and IUO through commercialization, we help biotech and pharma partners advance drug–diagnostic co-development efficiently and with reduced risk.

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. Already since 2022, we have attained IVDR certification in the field of transplantation diagnostics for both HLA typing reagents and analysis software.

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. More importantly, our regulatory experience de-risks the CDx development strategy and reduces complexity towards market authorization and commercialization.

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.

Our easy-to-use and efficient 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.

• Faster path from exploratory biomarker to IVD registration, through integrated assay development and regulatory expertise
• Reduce timelines and technical risk with proven assay platforms and pre-validated workflows.
• De-risk biomarker and assay strategies early through feasibility assessment, assay design, and performance optimization.
• Enable efficient regulatory execution with experience supporting IVDR-compliant development and submissions.
• Provide continuity from research to commercialization, supporting programs from RUO through clinical development and market launch.

From biomarker strategy and assay development to regulatory submission and commercialization, GenDx supports biotech and pharma partners throughout the CDx lifecycle. Contact our CDx team to discuss your program and discover how we can help accelerate development and reduce risk.