- GenDx can develop a CDx from Idea to IVD, for any gene of interest. Development trajectories and timelines differ when starting from a CE marked device (for different intended purposes), from a Research Use Only (RUO) device or from a prototype or concept. The technical validation of the CE marked and RUO solutions may be used for streamlined development.
- GenDx does already have CE marked devices for transplantation purposes targeting HLA-A, -B, -C, -DRB1, -DRB3/4/5, -DQB1, -DQA1, -DPB1 and DPA1. Additionally, GenDx offers RUO solutions for KIR, MICA and MICB gene analysis. Alternatively, we can use our expertise in molecular diagnostic solutions to design and develop your CDx from Idea to IVD. It follows that such a development from Idea to IVD will take longer than starting from a CE marked kit.
