Alternative Name
BRAF V600
Methodology
Molecular
Test Description

Bi-directional sequencing of exon 15 of the BRAF gene, which includes qualitative detection of V600 mutations E, K, D, and others, plus other significant exon 15 mutations.  For solid tumors, tumor enrichment is performed before extraction. Expanded coverage for BRAF exons 11 & 15 is available in the RAS/RAF Panel. Testing is available separately or in combination with HRAS, KRAS, and NRAS in the RAS/RAF Panel. Testing is approved for specimens from the state of New York. 

Clinical Significance

Useful in selection of melanoma patients for vemurafenib therapy, for determination of prognosis in thyroid and colon cancers, for predicting response to anti-EGFR therapy in colon cancer, and as aid to diagnosis of hairy cell leukemia.

Specimen Requirements
  • FFPE solid tumor tissue: Paraffin block is preferred. Alternatively, send 1 H&E slide plus 5-10 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative. Do not use zinc fixatives.
  • Fine needle aspirate (FNA): Requisition must note specimen is FNA. Fresh cells in suspension, unstained air-dried smears (approx. 6-8 slides), or FFPE cell blocks are acceptable if pathologist attaches note verifying sample has >30% tumor or abnormal cells (required). Minimum 10^6 cells.
  • Peripheral blood: 5 mL in EDTA tube.
  • Bone marrow: 2 mL in EDTA tube.
Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. All slides can be packed at room temperature.

CPT Code(s)*
81210
Turnaround Time

7 days

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.