Companion diagnostic
A companion diagnostic is a test the FDA requires before a particular drug can be prescribed.
See the technology entry. Examples: 22C3 PD-L1 for pembrolizumab, FoundationOne CDx for many, myChoice CDx for niraparib/olaparib.
Pages like this
not linked directly; found by shared links- ProductFoundationOne CDx / Liquid CDx
Shares Regulators recognise each other's companion diagnostic approvals, Genomic profiling, Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaA commons for leftover trial biospecimens with standard access for approved research
Shares A fund for prospective validation of academic biomarkers and companion diagnostics, Companion diagnostics, Biomarkers are not validated or standardised.
- ProductOncotype DX
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.
- TermHER2-low and HER2-ultralow
Shares Test the drug in biomarker-negative patients too, so the biomarker can be validated, Companion diagnostics, Knowledge reaches practice too slowly, Biomarkers are not validated or standardised.
- IdeaPublish each laboratory's biomarker proficiency results
Shares Companion diagnostics, Fragmented care and guideline gaps, Biomarkers are not validated or standardised.
- IdeaRescue the biological samples from failed trials for biomarker research
Shares A formal regulatory route for validating a biomarker on archived trial samples, Biomarkers are not validated or standardised.
- IdeaPathologists order genomic profiling automatically at diagnosis of advanced cancer
Shares Companion diagnostics, Fragmented care and guideline gaps, Biomarkers are not validated or standardised.
- TermBiopsy
Shares Biomarker, Genomic profiling.