|Trade Name||BIOMERIEUX THXID BRAF ASSAY KIT|
|Classification Name||somatic gene mutation detection system|
|Docket Number|| 13M-0709|
|Notice Date|| 06/14/2013|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the thxid braf kit for use on the abi 7500 fast dx real-time pcr instrument. This device is indicated for: 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 paraffinembedded (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].