ALK (D5F3)
Use
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).
Special Instructions
Not provided.
Limitations
Not provided.
New York Approved
Methodology
Immunoassay (IHC)
Biomarkers
Result Turnaround Time
1-2 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Preferred: FFPE tissue block, or one unbaked, unstained slide for H&E staining (required) and two to three positively charged unstained slides (4‑5 microns), identifiers must match requisition.
Storage Instructions
Use cold pack for transport, making sure cold pack is not in direct contact with specimen.