EGFR Mutation Analysis

Casandra

Casandra Test Code LC58614Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID N/ACPT Codes 81235, 88381

EGFR Mutation Analysis

Also known as: therascreen EGFR RGQ PCR Kit

Clinical Use

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Use

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.

Special Instructions

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.

Limitations

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.

Test Details