ALK (D5F3) by Immunohistochemistry with Reflex to ALK Gene Rearrangements by FISH

Also known as: ALK REFLEX

Clinical Use

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

Not provided.

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.

Test Details

New York Approved

Methodology

Immunoassay (IHC)

Biomarkers

2 components

ALK (D5F3) by Immunohistochemistry • IHCALK Gene Rearrangements by FISH • FISH

LOINC Codes

Order Codes

31208-2 - Specimen source
47303-3 - ALK Ag Tiss Ql ImStn
94736-6 - Tissue block ID Spec

Result Turnaround Time

1-5 days

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.