{"entity":{"id":"thxid-braf","kind":"drug","name":"THxID BRAF Kit","aka":["THXID BRAF Kit","bioMérieux THxID BRAF"],"tldr":"bioMérieux's BRAF test for melanoma, approved with dabrafenib and trametinib in 2013; the FDA's device database records its approval as withdrawn in 2024.","summary":"bioMérieux's THxID BRAF Kit was approved on 29 May 2013 (PMA P120014) as the companion diagnostic for dabrafenib (V600E) and trametinib (V600E or V600K) in melanoma; a supplement on 27 June 2018 added encorafenib with binimetinib. The FDA PMA database records a withdrawal date of 24 June 2024, although the kit still appeared on the FDA companion diagnostic list when both were read on 3 November 2026. Other approved tests, such as FoundationOne CDx, carry BRAF claims for these drugs.","status":"withdrawn","asOf":"2026-11-03","links":[{"label":"FDA PMA P120014","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120014"},{"label":"FDA: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":["cobas-4800-braf-v600","braf-v600e"],"cancers":["melanoma"],"sections":[],"technologies":["companion-diagnostic"],"targets":["braf"],"drugs":["dabrafenib","trametinib","encorafenib","binimetinib"],"companies":["biomerieux"],"institutions":[],"pathways":[],"terms":["pcr","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["PMA P120014 shows a withdrawal date of 24 June 2024 in the FDA PMA database (read 3 November 2026)."],"brand":"THxID BRAF","modality":"PCR companion diagnostic test (BRAF V600E and V600K, melanoma tissue)","mechanism":"Detects BRAF V600E and V600K mutations in DNA from melanoma tissue.","approvals":[{"region":"US","year":2013,"indication":"Companion diagnostic for dabrafenib (V600E) and trametinib (V600E or V600K) in melanoma"},{"region":"US","year":2018,"indication":"Companion diagnostic for encorafenib with binimetinib"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/thxid-braf/","neighbours":{"drug":[{"id":"binimetinib","kind":"drug","name":"Binimetinib","route":"/drugs/binimetinib/"},{"id":"cobas-4800-braf-v600","kind":"drug","name":"cobas 4800 BRAF V600 Mutation Test","route":"/drugs/cobas-4800-braf-v600/"},{"id":"dabrafenib","kind":"drug","name":"Dabrafenib","route":"/drugs/dabrafenib/"},{"id":"encorafenib","kind":"drug","name":"Encorafenib","route":"/drugs/encorafenib/"},{"id":"trametinib","kind":"drug","name":"Trametinib","route":"/drugs/trametinib/"}],"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":"biomerieux","kind":"company","name":"bioMérieux","route":"/companies/biomerieux/"}],"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/"}]}}