Methodology
Immunohistochemistry (IHC)
Test Description
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).
Specimen Requirements
- A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
or - One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered
- Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Storage & Transportation
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
CPT Code(s)*
88342 x 1 or 88341 x 1
Turnaround Time
Global: 48 hours, Tech-Only (stain only): 24 hours
Level of Service
Global
Stain Only
New York Approved
Yes