Lung Cancer Mutation Panel (EGFR, KRAS, ALK)

Lung Cancer Mutation Panel (EGFR, KRAS, ALK)

Test Code

91216
81235, 81275, 81276, 88271 (x2), 88274
⁠⁠⁠⁠⁠⁠⁠CPT coding may differ dependent on payer rules which may impact prior authorization testing.
Please direct any questions regarding CPT coding to the payer being billed.
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
91216
81235, 81275, 81276, 88271 (x2), 88274
⁠⁠⁠⁠⁠⁠⁠CPT coding may differ dependent on payer rules which may impact prior authorization testing.
Please direct any questions regarding CPT coding to the payer being billed.
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

Lung Cancer Mutation Panel (EGFR, KRAS, ALK) - 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.

Test Details

Includes

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

Methodology

See individual tests

Assay Category

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.

Reference Range(s)

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

Alternative Name(s)

Non-Small Cell Lung Cancer (NSCLC)

LOINC® Codes, Performing Laboratory

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

Methodology

See individual tests
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.

Reference Range(s)

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

Alternative Name(s)

Non-Small Cell Lung Cancer (NSCLC)

Preferred Specimen(s)

Formalin-fixed, paraffin-embedded tissue

Alternative Specimen(s)

12 unstained charged (+) slides

Minimum Volume

8 unstained charged (+) slides

Collection Instructions

Do not reject specimens. Send to laboratory for screening.

Transport Container

Formalin-fixed, paraffin embedded tissue block

Transport Temperature

Room temperature

Specimen Stability

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

Setup Schedule

Formalin-fixed, paraffin-embedded tissue
12 unstained charged (+) slides
8 unstained charged (+) slides

Do not reject specimens. Send to laboratory for screening.

Formalin-fixed, paraffin embedded tissue block
Room temperature
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance 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.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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