ALK Gene Rearrangements by FISH, Lung
Ordering Recommendation

Screening test for all ALK fusions. Use this test if the companion diagnostic test for crizotinib is required. Does not identify the translocation partner or variant.

Fluorescence in situ Hybridization
3-7 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
Tumor tissue.  
Specimen Preparation
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)  
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated.  
Unacceptable Conditions
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.   
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable  
Reference Interval
By report
Interpretive Data

Compliance Statement A: For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay. Analyte Specific Reagent. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, the FDA has determined that such clearance or approval is not necessary.
CPT Code(s)
Component Test Code*Component Chart NameLOINC
2006127ALK by FISH - Result
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
  • ALK (EML4) Rearrangement
  • Lung Cancer, ALK (2p23) Rearrangement, FISH, Tissue
  • Lung Carcinoma
  • Non-Small Cell Lung Cancer
  • Soft-FLCA