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TEST:
THXID® BRAF Kit

Company:
bioMérieux
Type:
FDA Approved
The THXID-BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue. The THXID-BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist®].
Cancer:
Melanoma
Gene:
BRAF (B-raf proto-oncogene)
Drug:
Braftovi (encorafenib), Mekinist (trametinib), Mektovi (binimetinib), Tafinlar (dabrafenib)
Method:
PCR
Approvals
Date
Cancer
Gene
Drug
By
05/29/13
FDA
Confirmatory trial(s)