BRAF Gene Mutation Analysis, Melanoma

CPT: 81210; 88381
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Test Details


The US Food and Drug Administration (FDA) has approved TKI inhibitor vemurafenib and debrafenib for the first-line treatment of patients with unresectable or metastatic melanoma whose tumors have a BRAF V600E mutation, and trametinib for tumors with either V600E or V600K mutations. These mutations make up greater than 90% of identified BRAF mutations. In addition, pembrolizumab and nivolumab have been approved by the FDA for treatment for disease progression after treatment with ipilimumab and V600 mutation positive patients with unresectable or metastatic melanoma with disease progression and prior treatment with a BRAF inhibitor. The NCCN guideline also suggests using both pembrolizumab and nivolumab as options for first-line treatment as both drugs have higher response rates and less toxicity compared to ipilimumab. BRAF is an important member of the mitogen-activated protein kinase (MAPK) pathway that influences cell proliferation. BRAF mutations are found in approximately 50% of melanoma tumors.


This assay is able to detect 5% mutation in a background of wild-type DNA.


Amplification refraction mutation-specific system (ARMS) polymerase chain reaction (PCR)

Specimen Requirements


Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides


Formalin-fixed, paraffin-embedded tissue block or eight unstained slides and one matching H&E-stained slide at 5 μM.

Minimum Volume

Four unstained slides at 5 μM and one matching H&E-stained slide. The minimum total tumor surface area needed for this assay is 40 mm² for 5-μm sections and >80% tumor cells.


Formalin-fixed, paraffin-embedded (FFPE) tissue blocks or slides

Storage Instructions

Ship at room temperature. Store FFPE block or slides at room temperature.

Causes for Rejection

Tumor block containing insufficient tumor tissue; broken or stained slides

Clinical Information

Special Instructions

Please provide a copy of the pathology report. Direct any questions regarding this test to customer service at 800-345-4363. BRAF testing will be delayed if the pathology report is not received.


Coit DG, Thompson JA, Andtbacka R, et al. Melanoma, version 4.2014. J Natl Compr Canc Netw. 2014 May; 12(5):621-629. 24812131
Kudchadkar R, Gibney G, Sondak VK. Integrating molecular biomarkers into current clinical management in melanoma. Methods Mol Biol. 2014; 1102:27-42. 24258972
Pakneshan S, Salajegheh A, Smith RA, Lam AK. Clinicopathological relevance of BRAF mutations in human cancer. Pathology. 2013 Jun; 45(4):346-356. 23594689
THxID®-BRAF [package insert]. Marcy-l'Etoile, France: bioMérieux SA; 2013.


Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481110 BRAF Analysis, Melanoma 481111 Results: 58483-9
481110 BRAF Analysis, Melanoma 481112 Indications: 42349-1
481110 BRAF Analysis, Melanoma 481113 Specimen Location: N/A
481110 BRAF Analysis, Melanoma 481114 Specimen Type: 31208-2
481110 BRAF Analysis, Melanoma 481115 Block Number: N/A
481110 BRAF Analysis, Melanoma 481082 Nucleotide Change: 48004-6
481110 BRAF Analysis, Melanoma 481083 Amino Acid Change: 48005-3
481110 BRAF Analysis, Melanoma 481116 Background: 8251-1
481110 BRAF Analysis, Melanoma 481117 Methodology: 49549-9
481110 BRAF Analysis, Melanoma 481118 References: N/A
481110 BRAF Analysis, Melanoma 481084 Director Review: 72486-4
481110 BRAF Analysis, Melanoma 480903 Microdissection Performed 8100-0

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