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Epidermal Growth Factor Receptor (EGFR) Gene Mutation Analysis, Non−Small-cell Lung Cancer (Single-base Extension)
- Erlotinib Responsiveness in NSCLC, EGFR Mutation Analysis
- Gefitinib Responsiveness in NSCLC, EGFR Mutation Analysis
- IRESSA® Responsiveness in NSCLC, EGFR Mutation Analysis
- Non−Small-cell Lung Cancer, EGFR Mutation
- Tarceva® Responsiveness in NSCLC, EGFR Mutation Analysis
Non−small-cell lung cancer (NSCLC) is the leading cause of death from cancer in both men and women in the US. A subgroup of NSCLC patients has shown clinical responsiveness to the EGFR inhibitors gefitinib (Iressa®) and erlotinib (Tarceva®). In the majority of patients with highly responsive tumors, the tumor contains somatic mutations within the EGFR tyrosine kinase domain. The presence of a somatic EGFR mutation is significantly associated with deferential responsiveness or resistance to gefitinib and erlotinib and is strongly predictive of prolonged survival in NSCLC patients.
The EGFR test is designed to detect mutations in exon 18, 19, 20, and 21 of the EGFR gene. These mutations account for >99% of all reported EGFR mutations in NSCLC patients. Samples with results reported as "no mutation detected" may harbor EGFR mutations that are not detected by the assay.
Detection of mutation is dependent on sample integrity and the amount of amplifiable DNA present in the specimen. The methods used in this assay are highly selective and, depending on the total amount of DNA present, can detect approximately 2% to 20% of mutant in a background of wild-type genomic DNA.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
SNaPshot Multiplex PCR (primer extension-based method)
Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides from NSCLC or extracted DNA
Five unstained slides and one matching H&E-stained slide at 10 μM or formalin-fixed, paraffin-embedded tissue block or 25 μL DNA at 10 ng/μL
Two unstained slides and one matching H&E-stained slide at 10 μM (Note: Samples with >4 mm² and ≥50% tumor content are preferred.)
Submit blocks/slides at room temperature. Freeze DNA.
Causes for Rejection
Tumor block containing insufficient tumor; tissue or tumor fixed in a heavy metal fixative; broken or stained slides
Please provide a copy of the pathology report. Please direct any questions regarding this test to customer service at 800-345-4363. A subsequent blood sample may be requested in order to confirm the somatic origin of an identified mutation.