Technology Platforms for CDx Development
Our CDx Technology Portfolio comprises immunogenomics technologies, flexible assays, and bioinformatics solutions designed to support biomarker research, translational studies, clinical development, and companion diagnostic programs across HLA and other clinically relevant immune genes.
Core Technology Platforms
- High-resolution HLA, KIR, MICA, MICB and immune gene profiling
- Long- and short-read NGS workflows (PCR- or capture-based enrichment)
- Cell-free DNA and genomic DNA analyses
- Chimerism monitoring solutions
- Proprietary bioinformatics and allele-calling software
- Flexible singleplex and multiplex assay formats
- qPCR, dPCR, NGS and Sanger sequencing solutions
Our companion diagnostic development capabilities are built on a foundation of proven diagnostic technologies and products used in transplantation and immunogenomics. Explore our registered diagnostic products and workflows to learn more about the technologies that underpin our CDx development capabilities.
Proven Immunogenomics Expertise
GenDx has more than a decade of experience developing NGS-based solutions for high-resolution characterization of HLA and other complex immune-related genes. These capabilities have continuously evolved to support both transplantation diagnostics and emerging precision medicine applications. Our portfolio includes solutions for Class I and II HLA genes, non-classical HLA genes, and other complex immune-related genes such as KIR, MICA, and MICB, available in both singleplex and multiplex formats. (Not all products are CE marked, availability of products in each country depends on local regulatory market authorization status).
Along with amplification solutions, GenDx offers proprietary library preparation workflows, known for their ease-of-use and efficiency. Additionally, our proprietary analysis software, NGSengine®, is a widely adopted for NGS-based typing of highly polymorphic immune genes. NGSengine supports high analytical accuracy and reproducibility through validated workflows and robust allele-calling algorithms. Together with our assay and workflow design expertise, these capabilities facilitate the development of fit-for-purpose solutions.
Supporting Precision Immunotherapy Development
As HLA-restricted and other precision immunotherapy approaches continue to advance, robust characterization of HLA and related immune genes is becoming increasingly important for biomarker development and patient selection. This trend reflects the growing recognition of HLA as a key factor in precision medicine and immunotherapy development.
GenDx’s expertise in high-resolution immunogenomics enables precise characterization of these complex genomic regions, supporting translational research, patient stratification strategies, and companion diagnostic development. Our solutions combine flexible assay design, scalable multiplex workflows, and robust analysis software to deliver consistent and reproducible performance.
Discuss Your CDx Strategy
Whether you are evaluating a biomarker strategy, developing a companion diagnostic, or planning your regulatory pathway, our CDx team can help. Contact us to discuss your program and explore how GenDx can support your development goals.
