A reliance pathway for companion diagnostics so the test arrives with the drug
Targeted cancer drugs often reach a country years before the test needed to select patients is approved there. Recognising other regulators' test approvals would close the gap.
In vitro diagnostic regulation has fragmented further since the EU IVDR: a companion diagnostic cleared by FDA as a PMA needs a separate notified-body assessment in Europe and different routes in Japan, China and Brazil. Because the drug is unusable without the test, this delay is a drug access delay. The proposal is a reliance route under which a companion diagnostic approved alongside a drug by a WHO-listed authority is accepted for that indication, with local requirements limited to laboratory accreditation and proficiency testing.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.
Pages like this
not linked directly; found by shared links- IdeaRegulators recognise each other's companion diagnostic approvals
Shares Companion diagnostic, Companion diagnostics, Regulatory divergence between regions, Biomarkers are not validated or standardised.
- IdeaDrug labels must state which biomarker assays were validated and how they compare
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaLock the biomarker cut-off before phase 3, and publish it
Shares Companion diagnostic, Biomarkers are not validated or standardised.
- IdeaPay for new biomarker tests only while evidence of clinical utility is being collected
Shares Companion diagnostic, Biomarkers are not validated or standardised.
- IdeaTest the drug in biomarker-negative patients too, so the biomarker can be validated
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaA fund for prospective validation of academic biomarkers and companion diagnostics
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaA formal regulatory route for validating a biomarker on archived trial samples
Shares Companion diagnostic, Biomarkers are not validated or standardised.
- ProductFoundationOne CDx / Liquid CDx
Shares Companion diagnostics, Biomarkers are not validated or standardised.