Roche Group member Ventana Medical Systems has submitted an application to US Food and Drug Administration (FDA) seeking premarket approval (PMA) for the Ventana ALK (D5F3) companion diagnostic (CDx) assay.
The company developed the CDx immunohistochemistry (IHC) test to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy, which inhibits the ALK gene.
According to the company, the submission was the fourth and final module, and application required by the FDA’s PMA process.
Ventana Medical Systems Companion Diagnostics lifecycle leader Doug Ward said: "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."
The new Ventana ALK (D5F3) CDx assay provides patients and physicians an efficient, standardised and cost-effective testing method to evaluate ALK protein expression and eligibility for available ALK inhibitor targeted therapy.
The company noted that IHS testing is mostly accessible on Ventana BenchMark XT instruments.
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."
Based on 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.
Image: Positive case of lung tissue stained for ALK with Ventana ALK (D5F3) CDx assay. Photo: courtesy of Ventana Medical Systems.