ALK FISH, Non-Small-cell Lung Cancer

CPT: 88271(x2); 88274
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Synonyms

  • Non Small Cell Lung Cancer FISH
  • NSCLC ALK FISH
  • Oncology FISH

Special Instructions

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


Expected Turnaround Time

4 - 6 days



Related Documents


Specimen Requirements


Specimen

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


Volume

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


Minimum Volume

Two slides (4- to 5-micron) on positively charged slides or one paraffin block


Container

Paraffin block


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.


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


Test Details


Use

Confirmation/identification of non-small-cell lung cancer (this is a test for the identification of NSCLC patients who may be eligible for treatment); qualitative/quantitative evaluation of ALK rearrangement


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)


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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
512084 ALK FISH, Lung, Non-Small Cell 512119 Specimen Type 66746-9
512084 ALK FISH, Lung, Non-Small Cell 512120 Cells Counted 64089-6
512084 ALK FISH, Lung, Non-Small Cell 512121 Cells Analyzed 64086-2
512084 ALK FISH, Lung, Non-Small Cell 512122 FISH Result 78233-4
512084 ALK FISH, Lung, Non-Small Cell 512133 Interpretation 78210-2
512084 ALK FISH, Lung, Non-Small Cell 512134 Director Review 48672-0
512084 ALK FISH, Lung, Non-Small Cell 512123 PDF 51967-8

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