EGFR Test

Epidermal growth factor receptor gene (EGFR) mutations are detected in approximately 10% to 20% of non-small cell lung cancer (NSCLC) tumors. EGFR mutations also are found in glioblastoma, breast, colorectal and pancreatic cancers as well as carcinoma of the head and neck. EGFR mutations have been correlated with response to EGFR tyrosine kinase inhibitors (TKIs) erlotinib or gefitinib. National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) guidelines recommend erlotinib and gefitinib only in patients with known EGFR mutations.

bioTheranostics EGFR Test

bioTheranostics EGFR Gene Mutation Testing detects mutations found in the tyrosine kinase domain of the EGFR gene. Patients with these mutations are more likely to respond to EGFR TKIs. The testing detects the most commonly found EGFR mutations – deletions in exon 19 (E19del) and a point mutation in exon 21 that results in substitution at codon 858 (L858R). These mutations account for ~90% of all EGFR mutations in NSCLC.

bioTheranostics EGFR Gene Mutation Testing:

  • Is a real-time PCR assay based on Scorpions® and ARMS® (allele specific PCR) technology. The sensitivity of Scorpions ARMS for detection of EGFR mutations is superior to the sensitivity of direct sequencing when a mixture of wild-type and mutant DNA is used
    • Detects 28 mutations in the tyrosine kinase domain of the EGFR gene, including:
      • L858R
      • L861Q
      • S768I
      • G719X
        • G719S (detects, does not distinguish)
        • G719A (detects, does not distinguish)
        • G719C (detects, does not distinguish)
        • 19 deletions of exon 19 (detects, does not distinguish)
    • 3 insertions in exon 20 (detects, does not distinguish)
    • Can detect 3% of mutant in a background of wild type genomic DNA

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