The THxID BRAF test is an FDA-approved, PCR-based qualitative companion diagnostic performed on DNA extracted from FFPE melanoma tissue for detection of two mutations in the BRAF gene: V600E (c.1799T>A) and V600K (c.1798_1799delinsAA).
This test is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E and/or V600K mutations for treatment with dabrafenib (Tafinlar®), trametinib (Mekinist®), or encorafenib (Braftovi®) in combination with binimetinib (Mektovi®)
- FFPE Tissue: Preferred: One (1) or two (2) FFPE blocks containing tumor tissue from most recent surgery or biopsy.
- Acceptable alternative: Two (2) unstained slides each with two 5 µm thick sections with at least 20 mm2 tumor surface area plus H&E slide. For smaller tumor surface areas, please contact NeoGenomics for number of sections needed.
- Unacceptable: Specimens preserved in alternative (non-formalin) fixatives, decalcified specimens, fresh or frozen tissue.
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature
- ThxID-BRAF [package insert]. Durham, NC: bioMerieux, Inc.; 2013
- List of cleared or approved companion diagnostic devices page. US FDA website. Accessed March 23, 2020.