Trial Design
Companion Diagnostic
A companion diagnostic is an in vitro device or imaging tool that provides information essential for the safe and effective use of a corresponding therapeutic product, typically by identifying patients eligible for treatment.
Companion diagnostics (CDx) are co-developed and co-approved with their associated therapy. Classic examples include HER2 testing for trastuzumab, BRAF testing for vemurafenib, and PD-L1 testing for pembrolizumab.
FDA regulates CDx under the In Vitro Diagnostic regulations and typically requires a PMA submission. Co-development is governed by the 2014 In Vitro Companion Diagnostic Devices guidance.
References
Related terms
Biomarker
A biomarker is a measurable biological characteristic (molecular, histologic, radiographic, or physiologic) used in clinical trials to indicate normal biology, disease state, treatment response, or prognosis.
Basket Trial
A basket trial is a clinical trial that tests one investigational therapy across multiple disease types (typically cancers) that share a common molecular biomarker or genetic alteration.
Umbrella Trial
An umbrella trial is a clinical trial that evaluates multiple targeted therapies in patients with a single disease, stratified by molecular or genetic subtype, under one master protocol.
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