- FDA: In order to obtain FDA approval for a companion diagnostic, the CDx needs to show robust analytical validity (accurately and reliably detect the biomarker of interest), clinical validity (predict the patient’s response to treatment) and clinical utility (appropriately inform patient management and improve patient outcomes). Additionally the CDx needs to comply to a high standard of manufacturing. Including the final CDx assay in a phase 3 pharmacological clinical trial maximizes the likelihood of drug/CDx co-approval, as both can be clinically validated by the results of the pharmacological trial. Understanding the CDx process to receive FDA or IVDR approval is crucial. Subsequently an application for authorization is submitted to FDA, often either a Premarket Notification 510(k) or a Premarket Approval (PMA). FDA will then assess the application including the analytical and clinical performance, and if applicable issue an approval of the Companion Diagnostic device.
- IVDR: In order to obtain IVDR approval for a companion diagnostic, a multi-step process needs to be followed. The process starts with the development of the CDx and the analytical and clinical performance evaluation. A comprehensive technical dossier is prepared and submitted to a Notified Body. Following a conformity assessment by a Notified Body and a scientific consultation with a competent authority (EMA), a final CE marking can be issued.
- GenDx was the first company in the field of transplant diagnostics complying to IVD Regulation (IVDR) and obtain IVDR certification for diagnostic use of GenDx’s HLA product portfolio. With GenDx’s ISO13485 compliant Quality Management System and our regulatory proficiency, we can effectively and efficiently support your CDx development.
