Companion Diagnostics โ Integration of Biomarker Tests with Therapeutic Labels
Why this matters
A companion diagnostic is not merely a biomarker test associated with treatment response. It is a regulated device that provides essential information for the safe and effective use of a specific therapeutic agent, including its indication, specimen type, platform, and cutoff values. Research tests or other assays targeting the same gene cannot be automatically substituted as equivalents. In practice, decisions must be made by consulting the most recent device labeling and therapeutic labeling applicable within the relevant jurisdiction. This concept does not propose individualized treatment choices for specific patients.
Interpretation boundary
This article explains the concept and the limits of the evidence. It does not provide diagnostic, testing, or treatment decisions for an individual patient.