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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)
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.
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.
Causes for Rejection
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.
|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|