Lung Cancer Mutation Panel (EGFR, KRAS, ALK)

Test Code

91216

CPT Codes
81235, 81275, 81276, 88271 (x2), 88274

Includes

Epidermal Growth Factor Receptor (EGFR) Mutation Analysis
KRAS Mutation Analysis
FISH, ALK 2p23 Rearrangement, Lung Cancer (NSCLC)

Preferred Specimen

Formalin-fixed, paraffin-embedded tissue block

Minimum Volume

1 block • 8 slides

Other Acceptable Specimens

12 unstained positively charged slides

Instructions

Do not reject specimens, send to laboratory for screening.

See individual tests for specific specimen requirements and stabilities

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable

Methodology
See individual tests

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 7 days

Reference Range

EGFR Mutation	Not detected
KRAS Mutation	Not detected
FISH, ALK 2p23 Rea, Lung Cancer (NSCLC)	See Laboratory Report

Clinical Significance

This panel is comprised of mutational analysis of the EGFR and KRAS genes and assessment for ALK locus rearrangement using an FDA-cleared FISH assay. These are the most common tumor-associated genetic changes that have been shown to have prognostic and therapeutic consequences in non-small cell lung cancer (NSCLC) and help guide therapy. Patients with EGFR mutations are generally responsive to EGFR-directed kinase inhibitors, whereas those with evidence of ALK gene rearrangements are candidates for treatment with the ALK inhibitor crizotinib. The presence of KRAS mutation in lung adenocarcinoma predicts for non-response to kinase inhibitors and for tumors with inferior outcome.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

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.