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ALK (D5F3)
- Immunohistochemistry (IHC)
VENTANA FDA approved ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) or ZYKADIA® (ceritinib).
Turnaround time
Global: 2 Day, Tech-Only (stain only): 1 Day
Level of Service
- Global
- Technical Only
New York Approved: Yes
Specimen Requirements
Paraffin Block: 1 Block sent with a cold pack. No zinc or mercury fixatives. H&E: 1 unstained slide cut at 4-5 microns required. Cut Slides: 2 to 3 unstained slides cut at 4-5 microns. 1 slide per antibody/probe ordered. >100 viable tumor cells per probe set. Positively charged slides in 10% NBF. No zinc or mercury fixatives.
Storage and Transportation
Storage & Transportation: Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection.
CPT Code(s)*
88342 x 1 or 88341 x 1
*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.
Last Updated: January 17, 2025