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For hours, walk-ins and appointments.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. 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.
Expected Turnaround Time
4 - 7 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
Specimen Requirements
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
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 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.
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 |
|---|---|---|---|---|---|---|
| 512136 | ALK FISH Reflex RET + ROS1 | 512119 | Specimen Type | 66746-9 | ||
| 512136 | ALK FISH Reflex RET + ROS1 | 512120 | Cells Counted | 64089-6 | ||
| 512136 | ALK FISH Reflex RET + ROS1 | 512121 | Cells Analyzed | 64086-2 | ||
| 512136 | ALK FISH Reflex RET + ROS1 | 512122 | FISH Result | 78233-4 | ||
| 512136 | ALK FISH Reflex RET + ROS1 | 512133 | Interpretation | 78210-2 | ||
| 512136 | ALK FISH Reflex RET + ROS1 | 512134 | Director Review | 48672-0 | ||
| 512136 | ALK FISH Reflex RET + ROS1 | 510939 | Reflex | N/A | ||
| 512136 | ALK FISH Reflex RET + ROS1 | 512123 | 51967-8 |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 510307 | RET + ROS1 Oncology FISH | 510928 | RET + ROS1 FISH | N/A | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 510307 | RET + ROS1 Oncology FISH | 510942 | Specimen Type | 31208-2 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 510307 | RET + ROS1 Oncology FISH | 510894 | Cells Counted | 62361-1 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 510307 | RET + ROS1 Oncology FISH | 510895 | Cells Analyzed | 62360-3 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 510307 | RET + ROS1 Oncology FISH | 510896 | FISH Result | 48674-6 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 510307 | RET + ROS1 Oncology FISH | 510270 | Interpretation | 62365-2 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 510307 | RET + ROS1 Oncology FISH | 510306 | Director Review | 48672-0 | |
| Reflex Table for Reflex | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 510307 | RET + ROS1 Oncology FISH | 512123 | 51967-8 | ||
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