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ALK FISH, Non-Small-cell Lung Cancer

Test Number 512084
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CPT

88271(x2); 88274
Synonyms
  • Non Small Cell Lung Cancer FISH
  • NSCLC ALK FISH
  • Oncology FISH
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  • Updated on 03/31/2025

Test Details

Methodology

Fluorescence in situ hybridization (FISH)

Result Turnaround Time

4 - 6 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Information

Related Documents

Use

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

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

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

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.

Limitations

Molecular mutations or chromosomal alterations not targeted by the probe included in this profile will not be detected. 

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

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.

Molecular mutations or chromosomal alterations not targeted by the probe included in this profile will not be detected. 

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

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 thick sections) on positively charged slides or one paraffin block (Note: This volume does not allow for repeat testing.)

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

Two slides (4- to 5-micron thick sections) on positively charged slides or one paraffin block (Note: This volume does not allow for repeat testing.)

Container

Paraffin block

Collection Instructions

Utilize sterile technique and Labcorp transport kits when possible.

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.

Utilize sterile technique and Labcorp transport kits when possible.

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

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 11502-2
Order Code512084
Order Code NameALK FISH, Lung, Non-Small Cell
Order Loinc
Result Code512119
Result Code NameSpecimen Type
UofM
Result LOINC66746-9
Order Code512084
Order Code NameALK FISH, Lung, Non-Small Cell
Order Loinc
Result Code512120
Result Code NameCells Counted
UofM
Result LOINC64089-6
Order Code512084
Order Code NameALK FISH, Lung, Non-Small Cell
Order Loinc
Result Code512121
Result Code NameCells Analyzed
UofM
Result LOINC64086-2
Order Code512084
Order Code NameALK FISH, Lung, Non-Small Cell
Order Loinc
Result Code512122
Result Code NameFISH Result
UofM
Result LOINC78233-4
Order Code512084
Order Code NameALK FISH, Lung, Non-Small Cell
Order Loinc
Result Code512133
Result Code NameInterpretation
UofM
Result LOINC78210-2
Order Code512084
Order Code NameALK FISH, Lung, Non-Small Cell
Order Loinc
Result Code512134
Result Code NameDirector Review
UofM
Result LOINC48672-0
Order Code512084
Order Code NameALK FISH, Lung, Non-Small Cell
Order Loinc
Result Code512123
Result Code NamePDF
UofM
Result LOINC11502-2