The EGFR Mutation Detection Kit is a real-time fluorescence PCR (real-time PCR) assay for the qualitative detection of the most prevalent epidermal growth factor receptor (EGFR) gene mutations in exons 18, 19, 20, and 21 in human tumor tissue DNA. Detecting EGFR mutations is essential for selecting non-small cell lung cancer (NSCLC) patients who are most likely to benefit from EGFR tyrosine kinase inhibitor (TKI) therapy.
WHY TEST FOR EGFR MUTATIONS?
EGFR is the protein product of the C-erbB-1 (HER-1) gene and a key driver of cell proliferation and survival. Activating mutations in EGFR exons 18-21 are found in a substantial proportion of NSCLC and — as demonstrated by the landmark IPASS trial and subsequent studies — predict sensitivity to EGFR-TKIs such as gefitinib. These mutations alter the intracellular ATP-binding domain of EGFR, enhancing drug binding. The kit detects the seven most clinically relevant EGFR mutations:
• Exon 19 deletions (DEL19) — approximately 45% of all EGFR mutations, including 2235-2249del15 and 2236-2250del15
• Exon 21 L858R point mutation — approximately 40-45% of mutations
• Exon 21 L861Q point mutation
• Exon 18 G719X point mutations — approximately 5% of mutations
• Exon 20 S768I point mutation
• Exon 20 insertions (INS20) — approximately 1% of mutations
• Exon 20 T790M — the key acquired-resistance mutation, detected in up to 50% of tumors from patients with secondary TKI resistance
KEY FEATURES
• Detects 7 EGFR mutation types across exons 18, 19, 20, and 21 in a single run
• 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 of 1% mutant allele
• Excellent precision: coefficient of variation (CV) ≤5%
• CE marked, for professional in vitro diagnostic use
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, ABI 7500, Hongshi SLAN®-48P, and Hongshi SLAN®-96S 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 EGFR mutation testing to guide targeted therapy selection for non-small cell lung cancer (NSCLC) 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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