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A companion diagnostic is a test the FDA requires before a particular drug can be prescribed.
A companion diagnostic is a test that the FDA requires before a particular drug can be prescribed, tying the medicine to the assay that identifies who should receive it. Examples include the 22C3 PD-L1 assay for pembrolizumab, FoundationOne CDx for many targeted drugs and myChoice CDx for niraparib and olaparib; the fuller account is in the Companion diagnostics technology entry. The term features in the bottlenecks on unvalidated biomarkers, fragmented care and slow knowledge diffusion, and in the LUNGevity Foundation collection. Ideas that address it include mutual recognition of companion diagnostic approvals between regulators, a reliance pathway so the test arrives with the drug, locking the biomarker cut-off before phase 3 and a fund for prospective validation of academic biomarkers.
Showing the technology this term belongs to: Companion diagnostics.
Shares Lock the biomarker cut-off before phase 3, and publish it, Pay for new biomarker tests only while evidence of clinical utility is being collected, Drug labels must state which biomarker assays were validated and how they compare, Regulators recognise each other's companion diagnostic approvals.
Shares State biomarker testing coverage laws, Association for Molecular Pathology v. Myriad Genetics (2013), Companion diagnostics.
Shares cobas EGFR Mutation Test v2, Oncomine Dx Target Test, therascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF), Guardant360 CDx.
Shares Label, indication and label expansion, Medicare coverage with evidence development.
Shares Regulators recognise each other's companion diagnostic approvals, Genomic profiling, Guardant360 CDx, Companion diagnostics.
Shares A fund for prospective validation of academic biomarkers and companion diagnostics, Companion diagnostics, Biomarkers are not validated or standardised.
Shares State biomarker testing coverage laws, Association for Molecular Pathology v. Myriad Genetics (2013).
Shares A formal regulatory route for validating a biomarker on archived trial samples, A fund for prospective validation of academic biomarkers and companion diagnostics, Companion diagnostics.