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Companion Diagnostics

Definition
AI-generated

Companion diagnostics are tests (often an in vitro assay or sequencing panel) whose results are essential to decide whether a specific therapy is appropriate for a patient—typically codified on a drug’s label or in regulatory guidance.

Topics
Precision medicine
Related
Biomarker Genome-Wide Association Study (GWAS) Molecular Diagnostics

Why it matters in GWAS

Discovery pipelines that nominate somatic or germline biomarkers can feed companion-test development; biobank and tumor cohorts used for pharmacogenomic or oncology GWAS must align variant calling and ancestry with how the eventual diagnostic will be deployed.

Example usage

"The oncology protocol required FDA-cleared companion diagnostics for the targeted agent before randomization."

Biomarker Genome-Wide Association Study (GWAS) Molecular Diagnostics Precision Medicine Precision Oncology
Related-term network

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References

  • FDA. (2014). In Vitro Companion Diagnostic Devices. Guidance for Industry and Food and Drug Administration Staff.
← Common Variant Complementary DNA (cDNA) →

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