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ALK Gene Rearrangements by FISH, Lung
Ordering Recommendation
Screening test for all ALK fusions. Use if the companion diagnostic test for crizotinib is required. Does not identify the translocation partner or variant.
New York DOH Approval Status
Specimen Required
Tumor tissue.
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tumor tissue. Protect paraffin block and/or slides from excessive heat. Transport tissue block or 4 unstained, consecutively cut, 4-micron thick sections, mounted on positively charged glass slides in a tissue transport kit (ARUP supply #47808 recommended but not required) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787. (Min: 4 slides)
Room temperature. Also acceptable: Refrigerated.
Specimens fixed or processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives (B-4 or B-5). No tumor in tissue. Decalcified specimens.
Include surgical pathology report with reason for referral. The laboratory will not reject specimens that arrive without a pathology report but will hold the specimen until this information is received.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Methodology
Fluorescence in situ Hybridization (FISH)
Performed
Mon-Fri
Reported
3-7 days
Reference Interval
By report
Interpretive Data
Refer to report.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Analyte Specific Reagent (ASR)
Note
Hotline History
CPT Codes
88366
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 3000627 | ALK FISH Reference Number | |
| 3000628 | ALK FISH Source | 31208-2 |
| 3000629 | ALK FISH Result | 78205-2 |
| 3000703 | Scoring Method | 81304-8 |
| 3002935 | Total Cell Count | 78236-7 |
