ALK FISH With Reflex to RET and ROS1

CPT 88271(x2); 88274
Synonyms
  • Non Small Cell Lung Cancer FISH
  • NSCLC ALK FISH
  • Oncology FISH

Test Details

Turnaround Time

4 - 7 days

Use

Confirmation/identification of cancer-related alteration in non-small-cell lung cancer. This is a test for the identification of NSCLC patients who may be eligible for treatment.

Special Instructions

Pertinent clinical diagnostic information, including the pathology report documenting pulmonary origin and tumor grade, should be included with the specimen. A negative ALK FISH will reflex to RET and ROS1 FISH. Additional charges will be applied for the embedding process if formalin-fixed tissue is submitted.

Limitations

Use of fixatives other than 10% formalin or fixation times less than six hours or more than 72 hours may not yield reliable results. Suboptimal pre-analytic variables, including cold ischemia time outside the recommended guidelines, extended duration of fixation, fixation other than paraformaldehyde, and tissue decalcification, may negatively impact results. Results of the ALK FISH assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade and other known risk factors.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

Methodology

Fluorescence in situ hybridization (FISH)

Related Documents

References

Lindeman NI, Cagle PT, Aisner DL, et al. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. J Mol Diagn. 2018 Mar;20(2):129-159.29398453
Sanchez-Ares M, Cameselle-Teijeiro JM, Vzquez-Estvez S, et al. Fluorescence in situ hybridization analysis of the ALK gene in 2,045 non-small cell lung cancer patients from Northern Spain (Galicia). Oncol Lett. 2016 Aug;12(2):1403-1407.27446444
Schmid S, Garcia M, Cheng S, et al. Treatment patterns and outcomes in early-stage ALK-rearranged non-small cell lung cancer. Lung Cancer. 2022 Apr;166:58-62. Epub 2022 Feb 3.35183992
Singh A, Chen H. Optimal Care for Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer: A Review on the Role and Utility of ALK Inhibitors. Cancer Manag Res. 2020 Jul 30;12:6615-6628.32821158

Specimen Requirements

Information on collection, storage, and volume

Specimen

Lung; formalin-fixed paraffin-embedded (FFPE) tissue

Volume

Five slides (4- to 5-micron thick sections) on positively charged slides or one paraffin block

Minimum Volume

Four slides (4- to 5-micron thick sections) on positively charged slides or one paraffin block

Container

Paraffin block

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Tumor other than lung; use of fixatives other than 10% formalin; improper embedded prep; poor fixation <6 hours and >72 hours; decalcified bones or bone core; absence of tumor or quantity not sufficient for analysis

Collection

Time from tissue acquisition to fixation should be as short as possible; samples for ALK testing are fixed in 10% neutral buffered formalin for 6-72 hours; cytology specimens must be fixed in formalin.