Ventana Snags FDA Approval for ALK Companion Diagnostic Assay
Ventana Medical Systems’ anaplastic lymphoma kinase fusion gene immunohistochemsitry assay has won FDA approval as a companion diagnostic, indicated as an aid to patient identification for Pfizer’s Xalkori (crizotinib), the Tucson, Ariz., devicemaker announced Monday.
The ALK gene is an important biomarker in non-small cell lung cancer treatment as mutations of that gene are indicative of tumor activity. Fast-acting ALK immunohistochemistry assays offer an advantage over traditional fluorescent in situ hybridization ALK tests which can take several weeks to render results.
Xalkori works as an ALK inhibitor, designed to arrest important growth and survival pathways which have the potential to shrink or slow a tumor’s spread. It is indicated for metastatic non-small cell lung cancer patients with ALK-positive tumors.
The ALK assay is also available in Europe and China. — Jason Scott