{"entity":{"id":"cobas-4800-braf-v600","kind":"drug","name":"cobas 4800 BRAF V600 Mutation Test","aka":[],"tldr":"The BRAF test for melanoma approved as companion to vemurafenib in 2011 and to cobimetinib with vemurafenib in 2016.","summary":"Roche Molecular Systems' cobas 4800 BRAF V600 Mutation Test was approved on 17 August 2011 (PMA P110020) as the companion diagnostic for vemurafenib in BRAF V600E melanoma. A supplement on 7 November 2016 added cobimetinib with vemurafenib for V600E or V600K melanoma.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P110020","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110020"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["thxid-braf","braf-v600e"],"cancers":["melanoma"],"sections":[],"technologies":["companion-diagnostic"],"targets":["braf"],"drugs":["vemurafenib","cobimetinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["pcr","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"cobas 4800 BRAF V600 Mutation Test","modality":"Real-time PCR companion diagnostic test (BRAF V600, melanoma tissue)","mechanism":"Detects BRAF V600 mutations in DNA from melanoma tissue.","approvals":[{"region":"US","year":2011,"indication":"Companion diagnostic for vemurafenib in BRAF V600E melanoma"},{"region":"US","year":2016,"indication":"Companion diagnostic for cobimetinib with vemurafenib (V600E or V600K)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cobas-4800-braf-v600/","neighbours":{"drug":[{"id":"cobimetinib","kind":"drug","name":"Cobimetinib","route":"/drugs/cobimetinib/"},{"id":"thxid-braf","kind":"drug","name":"THxID BRAF Kit","route":"/drugs/thxid-braf/"},{"id":"vemurafenib","kind":"drug","name":"Vemurafenib","route":"/drugs/vemurafenib/"}],"biomarker":[{"id":"braf-v600e","kind":"biomarker","name":"BRAF V600E (and V600K)","route":"/biomarkers/braf-v600e/"}],"cancer":[{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"}]}}