EGFR Mutation Analysis

In non-small cell lung cancer, many mutations in EGFR are associated with responsiveness to EGFR tyrosine kinase inhibitor (TKI) therapy. In contrast, some mutations in EGFR are associated with resistance to EGFR TKI therapy, including T790M and EGFR exon 20 insertions. The T790M mutation is a known mechanism of resistance and is commonly associated with relapse following initial therapy with EGFR TKI.

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.

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).

SNaPshot Multiplex PCR (primer extension-based method)