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Lung Cancer Mutation Panel (EGFR, KRAS, ALK)
Test Code91216
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)
KRAS Mutation Analysis
FISH, ALK 2p23 Rearrangement, Lung Cancer (NSCLC)
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue
Minimum Volume
8 unstained charged (+) slides
Other Acceptable Specimens
12 unstained charged (+) slides
Instructions
Do not reject specimens. Send to laboratory for screening.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
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
See individual assays
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.