Company seeks US FDA premarket approval for lung cancer companion diagnostic
Ventana Medical Systems, Inc (AZ, USA) recently announced its US FDA application for premarket approval of the companion diagnostic assay termed Ventana ALK (D5F3) CDx Assay. The companion diagnostic immunohistochemistry test has been developed to identify ALK-positive lung cancer patients who could benefit from treatment with targeted therapy that inhibits the ALK gene.
Companion diagnostic tests are designed to confirm the presence of a specific biomarker. The detection of specific biomarkers can assist physicians in the selection of effective therapies for their patients, based on their individual characteristics.
Non-small-cell lung cancer is the most common subtype of lung cancer, and the leading cause of cancer-related deaths worldwide. Approximately 5% of non-small-cell lung cancer patients have an alteration to the ALK gene, which leads to the production of an abnormal ALK protein that causes cells to grow and spread.
The Ventana ALK (D5F3) companion diagnostic assay provides an practical, standardized and cost-effective testing method for the assessing ALK protein expression, and eligibility for available ALK inhibitor targeted therapy.
Doug Ward, Lifecycle Leader for Companion Diagnostics, Ventana Medical Systems, Inc., commented: “Premarket approval of the VENTANA ALK (D5F3) CDx Assay will enable more lung cancer patients to access ALK gene testing and obtain faster test results over current [methods]. We are very pleased about the potential impact of this important diagnostic in providing these patients access to drugs specifically designed to target the ALK mutation.”
