Lung Cancer (NSCLC), ROS1 (6q22) Rearrangement, FISH

Lung Cancer (NSCLC), ROS1 (6q22) Rearrangement, FISH

Test Code

91836
88271 (x2), 88274
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
91836
88271 (x2), 88274
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 (NSCLC), ROS1 (6q22) Rearrangement, FISH - ROS1 rearrangement has been identified in 1.7% of non small-cell lung cancer (NSCLC) by using a FISH assay. Treatment with ALK/MET tyrosine kinase inhibitors such as crizotinib (Xalkori(R)) has shown early evidence of therapeutic efficacy in ROS1-rearranged NSCLC (Bergethon, et al. J Clin Oncol. 2012;30:863-870)

Test Resources

Topic Brief

Non-Small Cell Lung Cancer (NSCLC): Laboratory Support of Diagnosis and Management

Test Details

Methodology

Fluorescence in situ Hybridization (FISH)

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)

See Laboratory Report

Alternative Name(s)

Crizotinib, FISH, Lung Cancer (NSCLC),Non-Small Cell Lung Cancer (NSCLC),Xalkori®,ROS1 (6q22) Rearrangement

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Fluorescence in situ Hybridization (FISH)
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)

See Laboratory Report

Alternative Name(s)

Crizotinib, FISH, Lung Cancer (NSCLC),Non-Small Cell Lung Cancer (NSCLC),Xalkori®,ROS1 (6q22) Rearrangement
Service Area must be determined

Preferred Specimen(s)

Formalin-fixed, paraffin-embedded tissue block

Alternative Specimen(s)

5x5 mm tumor tissue in culture transport medium • 4-5 microns sections on charged slide (x5)

Collection Instructions

Lung tissue biopsy, formalin fixed paraffin-embedded block or charged/+slides from formalin fixed paraffin embedded tissue. Specimen MUST be fixed with 10% neutral buffered formalin. Fixation between 6 and 48 hours is recommended. Pathology report must accompany paraffin block or slides.
Information required in this report includes: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis.

Transport Container

Formalin-fixed, paraffin-embedded tissue block

Transport Temperature

Room temperature

Specimen Stability

  • Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Setup Schedule

Service Area must be determined
Formalin-fixed, paraffin-embedded tissue block
5x5 mm tumor tissue in culture transport medium • 4-5 microns sections on charged slide (x5)
Lung tissue biopsy, formalin fixed paraffin-embedded block or charged/+slides from formalin fixed paraffin embedded tissue. Specimen MUST be fixed with 10% neutral buffered formalin. Fixation between 6 and 48 hours is recommended. Pathology report must accompany paraffin block or slides.
Information required in this report includes: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis.
Formalin-fixed, paraffin-embedded tissue block
Room temperature
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
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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