Ordering Recommendation

Detects ALK fusion proteins (IHC) and ALK gene rearrangements (FISH) in solid tumors.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Tumor tissue.

Specimen Preparation

Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen. Protect paraffin block and/or slides from excessive heat. Transport tissue block or 7 unstained (4-micron thick sections), positively charged 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). If sending precut slides, do not oven bake.

Storage/Transport Temperature

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

Unacceptable Conditions

Paraffin block with no tumor tissue remaining; specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens.


Include surgical pathology report.
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.


Immunohistochemistry (IHC)/Fluorescence in situ Hybridization (FISH)




1-5 days
If reflexed, add 3-5 days.

Reference Interval

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.

Compliance Category

Laboratory Developed Test (LDT)


Note: This test includes pathologist interpretation of results. Include surgical pathology report with specimen submitted for testing. Indicate tissue site on requisition. ALK (D5F3) by Immunohistochemistry will reflex to FISH if result is Equivocal or Positive. Additional charges apply.

Hotline History


CPT Codes

88342; if reflexed, add 88366


Component Test Code* Component Chart Name LOINC
2007325 ALK(D5F3) by IHC Reference Number 94736-6
2007327 ALK(D5F3) by IHC Result 47303-3
3003119 ALK Tissue Source 31208-2
* 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 D5F3 antibody staining
  • ALK D5F3 staining
  • Alk Gene Rearrangements by FISH
  • ALK rearrangement by IHC
  • ALK rearrangement staining
ALK (D5F3) by Immunohistochemistry with Reflex to ALK Gene Rearrangements by FISH