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ALK Gene Rearrangements by FISH, Lung
2006102
Ordering Recommendation
Screening test for all ALK fusions. Use this test especially if the companion diagnostic test for crizotinib is required.
Mnemonic
ALK GENE
Methodology
Fluorescence in situ Hybridization
Performed
Varies
Reported
3-7 days  
New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Submit With Order
Specimen Required
Patient Preparation
  
Collect
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) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800)522-2787 (kit is recommended but not necessary). (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.  
Remarks
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.   
Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable  
Reference Interval
By report  
Interpretive Data


See Compliance Statement A: www.aruplab.com/CS
Statement A: Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. 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, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. This test should not be regarded as investigational or for research use.
 
Note
 
CPT Code(s)
88366
Components
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.
Aliases
  • ALK (EML4) Rearrangement
  • Lung Cancer, ALK (2p23) Rearrangement, FISH, Tissue
  • Lung Carcinoma
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Soft-FLCA