Alternative Name
THXID-BRAF
Methodology
Molecular
Test Description
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).
Clinical Significance
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®)
Specimen Requirements
- 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.
Storage and Transportation
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Slides can be packed at room temperature
CPT Code(s)*
81210
New York Approved
Yes
Level of Service
Global
Turnaround Time
7 days
References
- 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.