Epidermal Growth Factor Receptor (EGFR) Gene Mutation Analysis, Non-Small-cell Lung Cancer

Test Code

489360

CPT Codes
81235

Preferred Specimen

"Formalin-fixed, paraffin-embedded (FFPE) tissue block or slides from NSCLC or extracted DNA
"

Minimum Volume

"Two unstained slides and one matching H&E-stained slide at 10 µM (Note: Samples with >4 mm2 and =50% tumor content are preferred.)
"

Instructions

"Submit blocks/slides at room temperature. Freeze DNA.
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.
"

Transport Container

"Slides or blocks
"

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

"Tumor block containing insufficient tumor; tissue or tumor fixed in a heavy metal fixative; broken or stained slides
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Methodology
"SNaPshot Multiplex PCR (primer extension-based method) "

FDA Status
"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. "

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
"

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.