ALK (D5F3) with Interpretation by Immunohistochemistry

Also known as: ALKD5F3 IP

Clinical Use

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

Not provided.

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.

Test Details

New York Approved

Methodology

Immunoassay (IHC)

Biomarkers

ALK

Protein

IHC

Expression • Categorical (e.g., Positive / Negative / Indeterminate)

LOINC Codes

Order Codes

31208-2 - Specimen source
94736-6 - Tissue block ID Spec

Result Codes

47303-3 - ALK Ag Tiss Ql ImStn

Result Turnaround Time

1-5 days

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.