ALK (D5F3) with Interpretation by Immunohistochemistry

Test Code

36928

CPT Codes
88342

Preferred Specimen

Paraffin-embedded tumor tissue in formalin fix (10% neutral buffered formalin) block

Minimum Volume

Tumor tissue: 3 slides

Other Acceptable Specimens

5 unstained (3- to 5-micron thick sections), positively charged slides

Instructions

Protect paraffin block and/or slides from excessive heat. If sending precut slides, do not oven bake.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Paraffin block with no tumor tissue remaining • Specimens fixed in any fixative other than 10% neutral buffered formalin

Methodology
Immunohistochemistry

FDA Status
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.

Setup Schedule

Set up: Mon-Fri; Report available: 1-5 days

Clinical Significance

Determine eligibility for tyrosine kinase inhibitor (TKI) therapy, primarily in individuals with pulmonary adenocarcinomas. Detects ALK fusion proteins.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.