Ventana Medical Systems, Inc. has announced it submitted a premarket approval (PMA) of its VENTANA ALK (D5F3) CDx Assay to the U.S. Food and Drug Administration (FDA).
The companion diagnostic (CDx) immunohistochemistry (IHC) test has the capacity to identify ALK-positive lung cancer patients, enabling them to receive specific individualized treatment with ALK gene inhibitors.
ALK gene fusions occur in about 5% of all non-small cell lung cancer patients, and result in the abnormal production of the ALK protein, causing cancer cells to grow and spread.
The VENTANA ALK (D5F3) CDx Assay can provide both patients and physicians an extremely effective, consistent, and cost-effective method to assess the presence of ALK protein in lung cancer tissue.
“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 FISH or molecular testing 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,” Doug Ward, Lifecycle Leader for Companion Diagnostics, Ventana Medical Systems, Inc, said in a press release.
The combination of an effective diagnostic strategy with lung cancer drug development programs can help accelerate drug approval and ultimately lead to the development of new and more effective therapies, with enhanced safety profiles.
Ventana has already worked with over 45 different partners and has more than 180 collaborative ongoing projects to develop and commercialize companion diagnostics in several different countries.
This was the last submission required by the FDA for a premarket approval. “We’re extremely pleased to have finalized the submission of the VENTANA ALK (D5F3) CDx Assay. PMA is the most stringent type of device marketing application required by the FDA. Our 4-step modular submission process for premarket approval is a major progression as it has enabled the FDA to review each module after submission and provide us with timely feedback. This helps mitigate potential delays early in the review process and ensures a more efficient and effective approval process,” Troy Quander, Vice President, Regulatory Affairs, Ventana Medical Systems, Inc, added in the press release.
