Roche Group subsidiary Ventana Medical Systems has submitted an application to US Food and Drug Administration (FDA) for premarket approval (PMA) of the Ventana ALK (D5F3) companion diagnostic (CDx) assay.
The CDx immunohistochemistry (IHC) test is being developed to identify ALK1-positive lung cancer patients, who may benefit from the treatment with targeted therapy that inhibits the ALK gene.
According to Ventana, the submission was the fourth and final module and application required by the FDA’s PMA process.
Ventana Medical Systems regulatory affairs vice-president Troy Quander said: "Our four-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."
IHS testing is mostly accessible on Ventana BenchMark XT instruments, noted the company.
Based on the individual characteristics of each person, CDx tests are designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients.
Ventana develops and markets instruments and reagents, which automate tissue processing and slide staining for cancer diagnostics.
Image: Positive case of lung tissue stained for ALK with Ventana ALK (D5F3) CDx Assay. Photo: courtesy of Ventana Medical Systems, Inc.