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Lung Cancer Mutation Panel (EGFR, KRAS, ALK)

Test Summary

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.

Aliases

  • Non-Small Cell Lung Cancer (NSCLC)

Specimen Collection

Special Instructions

N/A

Preferred Specimen

Formalin-fixed, paraffin-embedded tissue block

Minimum Volume

1 block • 8 slides

Instructions

Do not reject specimens, send to laboratory for screening.

See individual tests for specific specimen requirements and stabilities

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

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

Limitations

N/A

Other Acceptable Specimens

12 unstained positively charged slides

Unacceptable Specimens

N/A

Order Code

LUNGCX

EPIC (Premier) Code

LAB5207

Includes

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

CPT Code

  • 81235
  • 81275
  • 81276
  • 88271 (x2)
  • 88274

Billing Code

  • 671244
  • 671245
  • 671246
  • 671247
  • 671248

CPT Statement

CPT Statement

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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153

Reference Range

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

Setup Schedule / Expected Turnaround Time

Daily; Report available: 7 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

Formalin-fixed, paraffin-embedded tissue block

Minimum Volume

1 block • 8 slides

Instructions

Do not reject specimens, send to laboratory for screening.

See individual tests for specific specimen requirements and stabilities

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

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

Limitations

N/A

Other Acceptable Specimens

12 unstained positively charged slides

Unacceptable Specimens

N/A

Billing

CPT Code

  • 81235
  • 81275
  • 81276
  • 88271 (x2)
  • 88274

Billing Code

  • 671244
  • 671245
  • 671246
  • 671247
  • 671248

CPT Statement

CPT Statement

Result Information

Methodology

See individual tests

Testing Laboratory

N/A

Reference Range

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

Setup Schedule / Expected Turnaround Time

Daily; Report available: 7 days