ALK (D5F3) with Interpretation by Immunohistochemistry
Also known as: ALKD5F3 IP
Use
This test is used primarily in determining eligibility for tyrosine kinase inhibitor (TKI) therapy in individuals with pulmonary adenocarcinomas by detecting ALK fusion proteins. Positive immunohistochemistry (IHC) results may predict response to ALK inhibitors, aiding in targeted treatment strategies for patients with non-small cell lung cancer (NSCLC).
Special Instructions
This test includes pathologist interpretation, and a surgical pathology report should be submitted with the specimen. When multiple specimens are submitted, an order comment should indicate the preferred specimen for testing. If no preference is stated, PATHOLOGIST BLOCK SELECTION FEE may be added. The test should be electronically requested, with manual submission using the ARUP Immunohistochemistry Stain Form #32978 if electronic ordering is unavailable.
Limitations
This test has not been cleared or approved by the US Food and Drug Administration and is intended for clinical purposes in a CLIA-certified laboratory. Equivocal results from IHC may require confirmation with ALK Gene Rearrangements by FISH. Performance is dependent on the quality of the tissue specimen, and non-formalin-fixed samples are unacceptable. Results can be influenced by the presence of non-tumor tissue or by variations in tissue fixation and processing.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 31208-2
- 94736-6
- 47303-3
Result Turnaround Time
1-5 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Paraffin block or 5 unstained slides, positively charged
Collection Instructions
Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen. Transport using ARUP supplied tissue transport kit #47808. Do not oven bake slides if pre-cut.
Storage Instructions
Protect paraffin block and/or slides from excessive heat. Ship in a cooled container during summer if refrigerated.
Causes for Rejection
Paraffin block with no tumor tissue remaining; specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |