{"entity":{"id":"cobas-egfr-mutation-test","kind":"drug","name":"cobas EGFR Mutation Test v2","aka":[],"tldr":"The lung cancer gene test that became the first blood-based companion diagnostic the FDA ever approved.","summary":"Roche's cobas EGFR Mutation Test was approved in 2013 with erlotinib for EGFR-mutant non-small-cell lung cancer. Version 2 (PMA P150044, decision 28 September 2016 for the tissue claim; plasma claim granted in June 2016) added the T790M resistance mutation as the companion for osimertinib and, critically, allowed testing of plasma when tissue is unavailable, the first FDA-approved liquid biopsy companion diagnostic. Plasma sensitivity is lower than tissue, so a negative plasma result must be followed by tissue testing. The test is CE-marked and remains widely used where sequencing is not available.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA PMA P150044","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150044"}],"tags":["test"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["companion-diagnostic","liquid-biopsy"],"targets":["egfr"],"drugs":["erlotinib","osimertinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["companion-diagnostic-term","ctdna"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: an EGFR mutation makes an EGFR pill the first treatment; T790M after a first-generation pill points to osimertinib."],"brand":"cobas EGFR Mutation Test","modality":"Real-time PCR companion diagnostic test (tissue and plasma)","mechanism":"Allele-specific real-time PCR for 42 EGFR mutations in exons 18 to 21, including L858R, exon 19 deletions and T790M, from tumour tissue or plasma cell-free DNA.","approvals":[{"region":"US","year":2013,"indication":"EGFR exon 19 deletion / L858R companion diagnostic for erlotinib (v1)"},{"region":"US","year":2016,"indication":"v2: T790M for osimertinib; plasma testing (first liquid biopsy companion diagnostic)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cobas-egfr-mutation-test/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"drug":[{"id":"erlotinib","kind":"drug","name":"Erlotinib","route":"/drugs/erlotinib/"},{"id":"guardant360-cdx","kind":"drug","name":"Guardant360 CDx","route":"/drugs/guardant360-cdx/"},{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"}],"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}],"biomarker":[{"id":"egfr-exon-19-deletion","kind":"biomarker","name":"EGFR exon 19 deletion","route":"/biomarkers/egfr-exon-19-deletion/"},{"id":"egfr-l858r","kind":"biomarker","name":"EGFR L858R","route":"/biomarkers/egfr-l858r/"},{"id":"egfr-t790m","kind":"biomarker","name":"EGFR T790M","route":"/biomarkers/egfr-t790m/"}]}}