Recent Device Approvals: VENTANA ALK (D5F3) CDx Assay

The FDA has recently approved the VENTANA ALK (D5F3) CDx Assay to be marketed. This is a laboratory immunohistochemical (IHC) test that identifies whether the anaplastic lymphoma kinase (ALK) protein is present in a non-small cell lung cancer (NSCLC) tissue sample. If the test result indicates that the ALK protein is present, then the patient with NSCLC may be eligible for treatment with the cancer drug Xalkori® (crizotinib).

Xalkori is a drug used to treat patients with advanced (locally or metastatic) NSCLC who have ALK positive tumors. Xalkori selectively interferes with the ALK protein and stops cancer cell growth in NSCLC.