The BRAF V600E Mutation Detection Kit is a real-time fluorescence PCR (real-time PCR) assay for the qualitative detection of the BRAF V600E mutation in human tumor tissue DNA. The V600E point mutation — a T-to-A transversion at nucleotide 1799 of exon 15 of the BRAF gene — converts valine to glutamic acid, constitutively activating the BRAF serine/threonine kinase and driving tumor growth through the RAS/RAF/MEK/ERK (MAPK) signaling pathway.
WHY TEST FOR BRAF V600E?
BRAF is a proto-oncogene encoding a serine-threonine kinase that acts as a key signal transducer in the MAPK pathway, regulating cell growth, differentiation, and apoptosis. BRAF mutations are among the most common actionable oncogenic alterations in solid tumors, reported in approximately 66% of malignant melanoma and 15% of colorectal cancer, and are also found in thyroid cancer, lung cancer, liver cancer, and pancreatic cancer. About 90% of all BRAF mutations occur as the V600E variant on exon 15. BRAF V600E testing is clinically essential for:
• Diagnosis and prognosis evaluation of papillary thyroid carcinoma (PTC)
• Predicting resistance to anti-EGFR therapies (EGFR-TKIs and EGFR monoclonal antibodies such as cetuximab) in metastatic colorectal cancer — identifying patients unlikely to benefit from these drugs
• Guiding targeted therapy decisions with BRAF/MEK inhibitors before treatment initiation
KEY FEATURES
• ARMS-PCR combined with TaqMan probe technology for high specificity and sensitivity
• High-specificity amplification: ARMS primers amplify only when perfectly matched to the V600E target sequence
• Dual quality control: internal standard (HEX/VIC) and external standard reactions verify DNA quality and PCR integrity
• High sensitivity: limit of detection ≤1% V600E mutation against a 30 ng/µL wild-type background
• CE marked, for professional in vitro diagnostic use
CLINICAL VALIDATION
A multicenter clinical study of 1,333 patient samples — including thyroid cancer, colorectal cancer, and lung cancer — conducted across three university hospitals demonstrated a Kappa agreement of 0.99, 100% sensitivity, 98.75% specificity, and 99.32% total coincidence rate versus Sanger DNA sequencing as the reference method.
SPECIFICATIONS
• Specimen type: fresh tissue, frozen tissue, or paraffin-embedded (FFPE) tissue with confirmed thyroid, colorectal, or lung cancer lesions
• Methodology: ARMS-PCR + TaqMan probe real-time fluorescent PCR
• Packaging: 24 tests/kit
• Compatible instruments: Roche LightCycler® 480 and ABI 7500 Real-Time PCR systems
• Storage: ≤ -20°C, protected from light; shelf life 9 months
• Detection channels: FAM (mutation and external standard signals), HEX/VIC (internal standard signal)
TARGET USERS
Clinical laboratories, hospital pathology and oncology departments, and molecular diagnostic centers performing prognostic and companion diagnostic testing for melanoma, colorectal cancer, and thyroid cancer.
Note: For in vitro diagnostic use only. Results serve as clinical reference and should be interpreted by a clinician together with the patient's condition and other laboratory findings.
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