The KRAS Mutation Detection Kit is a real-time fluorescence PCR (real-time PCR) assay for the qualitative detection of the seven most prevalent KRAS gene mutations in codons 12 and 13 in human tumor tissue DNA. Detecting KRAS mutations is essential for identifying colorectal cancer patients who are unlikely to benefit from anti-EGFR antibody therapy.
WHY TEST FOR KRAS MUTATIONS?
KRAS encodes a 189-amino-acid small GTPase that acts downstream of the EGFR signaling pathway, regulating cell growth and proliferation. Activating KRAS mutations lock the protein in a constitutively active state, driving tumor progression independent of EGFR blockade. KRAS mutations occur in approximately 35-40% of colorectal cancer patients, with about 90% concentrated in codons 12 and 13 (roughly 70% in codon 12 and 30% in codon 13). In 2004, the FDA approved cetuximab for advanced metastatic colorectal cancer, and multiple studies subsequently confirmed that KRAS mutation status determines its efficacy: patients with KRAS mutations do not respond to cetuximab. KRAS testing is therefore essential to:
• Identify colorectal cancer patients who will not benefit from anti-EGFR monoclonal antibody therapy (e.g., cetuximab)
• Guide targeted therapy selection and avoid ineffective, costly treatment
• Support molecular profiling of colorectal cancer as part of guideline-recommended care
KEY FEATURES
• Detects the 7 most common KRAS mutations in codons 12 and 13 in a single run: Gly12Asp, Gly12Val, Gly12Ser, Gly12Cys, Gly12Ala, Gly12Arg, and Gly13Asp
• ARMS-PCR combined with TaqMan probe technology for high specificity and sensitivity
• High-specificity amplification: ARMS primers amplify only when perfectly matched to the target mutation sequence
• Dual quality control: internal standard (HEX/VIC) and external standard reactions verify DNA quality and PCR integrity
• High sensitivity: limit of detection ≤1% mutation against a 30 ng/µL wild-type background
• Excellent precision: coefficient of variation (CV) ≤5%
• CE marked, for professional in vitro diagnostic use
CLINICAL VALIDATION
A clinical study of 1,000 colorectal cancer patient samples — conducted across three university hospitals — compared the kit against Sanger DNA sequencing and reported a Kappa agreement of 0.99, 100% sensitivity, 99.26% specificity, and 99.60% total coincidence rate.
SPECIFICATIONS
• Specimen type: fresh tissue, frozen tissue, or paraffin-embedded (FFPE) tissue with confirmed tumor cells
• 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 KRAS mutation testing to guide anti-EGFR therapy selection for metastatic colorectal cancer patients.
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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