{"entity":{"id":"idea-reg-diagnostic-reliance-pathway","kind":"idea","name":"A reliance pathway for companion diagnostics so the test arrives with the drug","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Regulatory divergence between regions): FDA Oncology Center of Excellence, Project Orbis","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["companion-diagnostic"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":["b-regulatory-fragmentation","b-biomarker-validation"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Countries adopting diagnostic reliance reduce the gap between drug approval and reimbursed availability of its companion test from a median of over a year to under six months.","rationale":"Analytical and clinical validation of a companion test does not vary by geography, and the test's clinical utility was already established in the pivotal drug trial that every regulator reviews.","test":"Survey the drug-to-test availability gap for ten recent targeted oncology approvals across 20 countries to size the problem; then pilot reliance in three countries and remeasure.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":3},"route":"/ideas/idea-reg-diagnostic-reliance-pathway/","neighbours":{"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}