The Molecular Response BRAF V600E mutation test is a PCR-based test that detects the BRAF V600E mutation in both melanoma and colorectal tumors. The test is validated as a Laboratory Developed Test (LDT) and is run in our San Diego CLIA laboratory.
Melanoma
- BRAF mutations account for approximately 32-90% of melanoma cancer patients
- BRAF V600E mutations are biomarkers of response for BRAF inhibitors (e.g., Zelboraf™)
Colon
- BRAF mutations account for approximately 12-15% of colorectal cancer patients
- BRAF mutations are biomarkers of non-response to anti-EGFR therapies
CLINICAL SIGNIFICANCE
The BRAF V600E Mutation Detection Test will guide oncologists as they seek to determine what therapies a patient is most likely to respond to. Mutations in the BRAF gene are associated with response to BRAF inhibitor therapies and non-response to anti-EGFR therapies.
SPECIFIC MUTATIONS
Specifically detects the V600E mutation associated with a T > A transversion of nucleotide 1799 of the BRAF oncogene.
METHODOLOGY
Cells are lysed and genomic DNA is purified. Real-time PCR using a single primer set is used to amplify the region of the BRAF gene where the mutation site resides. Two fluorescent probes were used to specifically detect the wild-type and V600E mutant sequences. The detection level is as low as 1% mutant BRAF V600E.
ORDERING INFORMATION
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