How to tell them apart
A companion diagnostic is a test essential for the safe and effective use of a specific medicine. The US and the EU define and regulate it differently: under the IVDR, a CDx is Class C and requires consultation with a medicines authority. Use the IVDR page for EU obligations.
- Meaning 1 · Market SegmentsCompanion DiagnosticIVD that identifies patients who will benefit from a specific drug.Read the full definition
- Meaning 2 · RegulatoryCompanion Diagnostic (IVDR)IVD that is essential for the safe and effective use of a corresponding medicinal product to identify eligible patients or monitor treatment response.Read the full definition