LungSEQ Concurrent Panel, without PD-L1

LungSEQ Concurrent Panel, without PD-L1

Test Code

12184
81445, 88271 (x8), 88275 (x4)
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
12184
81445, 88271 (x8), 88275 (x4)
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

LungSEQ Concurrent Panel, without PD-L1 - This test is intended to be used for the mutational profiling of tumors from patients with Non-Small-Cell Lung Cancer in order to help prioritize and direct treatment. It may be useful for patients who have become refractory to prior therapies and are searching for investigational targeted therapies offered in clinical trials or for newly diagnosed patients who would like to know their mutational profile to inform treatment options with approved targeted therapies or for the identification of potential future clinical trials or future approvals of targeted therapies.

Test Resources

None found for this test
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Test Details

Includes

  • ALK Variant,
    AKT1 Variant
    BRAF Variant
    EGFR Variant
    ERBB2 (HER2) Variant
    KRAS Variant
    MAP2K1 (MEK1) Variant
    NRAS Variant
    PIK3CA (PI3K) Variant
    PTEN Variant
    ALK Rearrangement
    RET Rearrangement
    ROS1 Rearrangement
    MET Amplification

Methodology

Next Generation Sequencing • Fluorescence in situ Hybridization (FISH)

Assay Category

This test was developed and its performance characteristics determined by MedFusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

Reference Range(s)

See Laboratory Report

Alternative Name(s)

Lung Cancer,FISH,c-MET,Next Generation Sequencing,NSCLC,NGS,Non-Small Cell Lung Cancer (NSCLC),ALK,RET,ROS1

LOINC® Codes, Performing Laboratory

Service Area must be determined
ALK Variant,
AKT1 Variant
BRAF Variant
EGFR Variant
ERBB2 (HER2) Variant
KRAS Variant
MAP2K1 (MEK1) Variant
NRAS Variant
PIK3CA (PI3K) Variant
PTEN Variant
ALK Rearrangement
RET Rearrangement
ROS1 Rearrangement
MET Amplification

Methodology

Next Generation Sequencing • Fluorescence in situ Hybridization (FISH)
This test was developed and its performance characteristics determined by MedFusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

Reference Range(s)

See Laboratory Report

Alternative Name(s)

Lung Cancer,FISH,c-MET,Next Generation Sequencing,NSCLC,NGS,Non-Small Cell Lung Cancer (NSCLC),ALK,RET,ROS1
Service Area must be determined

Preferred Specimen(s)

Paraffin-embedded tissue accompanied by a circled H&E slide indicating the area to be examined collected in a sterile biohazard plastic bag or
19 formalin-fixed paraffin-embedded tissue slides and H&E slide collected in a slide holder

Alternative Specimen(s)

Paraffin-embedded tissue block or slides

Collection Instructions

Do not freeze. Do not reject.
Please submit pathology report for FFPE and slides. Specimen to be tested should contain a minimum of 10% tumor nuclei. Decalcified specimens are not acceptable.

All specimens must be accompanied with pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.

Transport Container

Paraffin-embedded tissue with H&E slide in biohazard plastic bag

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: Preferred
    Refrigerated: Acceptable
    Frozen: Unacceptable

Setup Schedule

Service Area must be determined
Paraffin-embedded tissue accompanied by a circled H&E slide indicating the area to be examined collected in a sterile biohazard plastic bag or
19 formalin-fixed paraffin-embedded tissue slides and H&E slide collected in a slide holder
Paraffin-embedded tissue block or slides
Do not freeze. Do not reject.
Please submit pathology report for FFPE and slides. Specimen to be tested should contain a minimum of 10% tumor nuclei. Decalcified specimens are not acceptable.

All specimens must be accompanied with pathology report. All FFPE specimens will be examined by a pathologist for confirmation and adequacy. Macrodissection if warranted is performed in the lab.
Paraffin-embedded tissue with H&E slide in biohazard plastic bag
Room temperature
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Service Area must be determined
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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