Determine eligibility for tyrosine kinase inhibitor (TKI) therapy, primarily in individuals with pulmonary adenocarcinomas. Detects ALK fusion proteins.
New York DOH Approval Status
Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen. Protect paraffin block and/or slides from excessive heat. Transport tissue block or 5 unstained (3- to 5-micron thick sections), positively charged 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. (Min. 3 slides). If sending precut slides, do not oven bake.
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
Paraffin block with no tumor tissue remaining; specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens.
This test code includes pathologist interpretation. Include surgical pathology report. IMMUNOHISTOCHEMISTRY ORDERING AND SUBMISSION DETAILS: Submit electronic request. If you do not have electronic ordering capability, use an ARUP Immunohistochemistry Stain Form (#32978) with an ARUP client number. For additional technical details, please contact ARUP Client Services at (800) 522-2787.
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
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.
Laboratory Developed Test (LDT)
This test includes pathologist interpretation of results. Include surgical pathology report with specimen submitted for testing. Indicate tissue site on requisition.
|Component Test Code*||Component Chart Name||LOINC|
|2007325||ALK(D5F3) by IHC Reference Number||57723-9|
|2007327||ALK(D5F3) by IHC Result||35474-6|
|3003119||ALK Tissue Source|
- ALK D5F3 antibody staining
- ALK D5F3 staining
- ALK rearrangement by IHC
- ALK rearrangement staining