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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test for melanoma, approved with dabrafenib and trametinib in 2013; the FDA's device database records its approval as withdrawn in 2024.
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.
Detects BRAF V600E and V600K mutations in DNA from melanoma tissue. Connects to BRAF.
| Region | Year | Indication |
|---|---|---|
| US | 2013 | Companion diagnostic for dabrafenib (V600E) and trametinib (V600E or V600K) in melanoma |
| US | 2018 | Companion diagnostic for encorafenib with binimetinib |
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Query for this drug: (TITLE:"THxID BRAF Kit" OR ABSTRACT:"THxID BRAF Kit" OR TITLE:"THxID BRAF" OR ABSTRACT:"THxID BRAF" OR TITLE:"THXID BRAF Kit" OR ABSTRACT:"THXID BRAF Kit" OR TITLE:"bioMérieux THxID BRAF" OR ABSTRACT:"bioMérieux THxID BRAF") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about THxID BRAF Kit, not a curated reading list.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares BRAF V600E (and V600K), Companion diagnostic, Encorafenib, Companion diagnostics and the tag test.
Shares BRAF V600E (and V600K), Companion diagnostic, Companion diagnostics, BRAF and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
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