At GenDx, we do everything in-house, from Research & Development to Regulatory Affairs ensuring an efficient and seamless process. In May 2022, GenDx became the first company in the field of transplantation diagnostics to attain IVDR certification for their HLA typing reagents and analysis software. Our analysis software NGSengine is recognized as the best-in-class solution for the analysis of NGS-based HLA typing, ensuring accuracy and reliability in analysing one of the most complex and heterogenous gene families.
We offer our cutting-edge technology and extensive expertise in molecular diagnostics for complex, polymorphic genes, such as immuno-related genes like HLA, KIR, and MICA/MICB. Together with our evidencable experience with IVDR, GenDx will be your knowledgeable and reliable partner in supporting the development of your CDx, organization of clinical performance studies, and registration of new CDx products.
Our portfolio
Our broad portfolio of products and analysis techniques enables the precise analysis of complex genes. We provide state-of-the-art diagnostics based on:
- Next-Generation Sequencing (NGS) – long- and short-read, PCR-based or capture-based enrichment, single locus or multiplex, library preparation, and sequence platform agnostic analysis software
- Sanger Sequencing – Reagents and analysis software for high-resolution Sanger sequencing-based HLA typing
- qPCR and dPCR– cfDNA (cell free DNA) and gDNA (genomic DNA) analysis & software
