- GenDx can facilitate the development of your requested assay from prototype concept to registered Companion Diagnostic IVD. Our team of Research & Development and Operational experts will support the development of a robust IVD and our Regulatory experts will facilitate an effective performance study application process for authorization of a clinical study to validate the clinical validity of the device.
- If applicable, your CDx can leverage technical validation of our currently CE marked devices for transplantation purposes, shortening development timelines. In alignment with your requirements, we will develop and design the clinical trial assay for use in interventional clinical trials or retrospective bridging studies. The IVD will be developed and validated, compliant with EU (IVDR) and/or US (FDA) regulations.
