ALK (D5F3) by Immunohistochemistry with Reflex to ALK Gene Rearrangements by FISH
Also known as: ALK REFLEX
Use
This test is used to detect ALK fusion proteins through immunohistochemistry (IHC) and ALK gene rearrangements via fluorescence in situ hybridization (FISH) in solid tumors. It is an important diagnostic tool for identifying cases where ALK inhibitors may be effective, primarily in treating certain non-small cell lung cancers. Detection of ALK rearrangements is clinically significant as it aids in the molecular profiling of tumors, helping to guide targeted therapy decisions. Positive IHC results with this test can predict response to ALK inhibitors.
Special Instructions
A pathologist's interpretation is included with the test results. The surgical pathology report with specimen details should be included with submissions. Indicate the tissue site clearly on the requisition form. If the IHC results are equivocal or positive, the test will reflex to FISH analysis, which may entail additional charges.
Limitations
The test does not identify specific partner genes in ALK rearrangements. The FISH analysis is designed to detect ALK rearrangements but does not identify all specific genetic changes. While the test is comprehensive for ALK-stated cases, rare cryptic rearrangements might not be detected. The test has not been cleared or approved by the FDA and is intended for clinical purposes only, albeit performed in a CLIA certified laboratory.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- 31208-2
- 47303-3
- 94736-6
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 7 unstained slides
Collection Instructions
Formalin fix (10 percent neutral buffered formalin) and paraffin embed the specimen. Protect from excessive heat.
Storage Instructions
Transport at room temperature. Refrigerated is also acceptable, and ship in a cooled container during summer months.
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 |