EGFR Mutational Analysis

Indication:  

Mutations (point mutations, insertions, deletions) in exons 18-21 of the epidermal growth factor receptor (EGFR) gene are found in a subset of non-small cell lung cancer (NSCLC). Mutations are found in KRAS wild-type tumors and are more frequently seen in patients without a smoking history. The presence of EGFR mutations may confer an improved response to EGFR-targeted therapy.

Methodology:  

This test is performed by PCR-based Sanger sequencing of DNA to examine the mutation status of exons 18-21 of EGFR.

Test Parameters:  

This assay will detect mutations present in exons 18 through 21 of EGFR. The sensitivity of the Sanger sequencing assay is 20% of variant sequence in the background of wild-type sequence.

Turnaround Time:

7-10 days

Sample Requirements:

• 10 ug of purified DNA, sent on dry ice

or

• Four to six unstained recut slides of formalin-fixed, paraffin embedded tissue containing adequate amounts of tumor to be analyzed (See Sensitivity.)
The area of tumor to be analyzed should be indicated by circling the area on the bottom side of the slide or in a separate H&E-stained guide section.
Please provide a copy of the corresponding pathology report.

CPT Codes:

81235

Additional charges may apply for tissue extraction.

The CPT codes provided 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 payer being billed.