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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
Turnaround Time

7 days

References
  1. ThxID-BRAF [package insert]. Durham, NC: bioMerieux, Inc.; 2013
  2. List of cleared or approved companion diagnostic devices page. US FDA website. Accessed March 23, 2020.
New York Approved
Yes
Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.