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Ventana Seeks FDA Premarket Approval for Lung Cancer CDx

NEW YORK (GenomeWeb) – Ventana Medical Systems, a Roche business, today announced it has submitted the ALK (D5F3) CDx Assay to the US Food and Drug Administration for premarket approval.

The immunohistochemistry-based companion diagnostic test is designed to identify ALK1-positive lung cancer patients who may benefit from treatment with targeted therapy that inhibits the ALK gene.  It is the enrollment testing method for Novartis' Zykadia (ceritinib) and Roche's alectinib ALK inhibitors currently undergoing clinical trials, a Ventana spokesperson said. Ventana's assay "provides patients and their physicians a highly efficient, standardized, and cost-effective testing method for the assessment of ALK protein expression and eligibility for available ALK-inhibitor targeted therapy," the firm said.

About 5 percent of non-small cell lung cancer patients have mutations in the ALK gene, leading to an ALK protein that causes cells to grow and spread, according to Ventana.

"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" Ventana's Doug Ward said in a statement.

This submission was the fourth and final step required by the FDA's pre-market approval process.

This process "is a major progression as it has enabled the FDA to review each module after submission and provide us with timely feedback," Ventana VP of Regulatory Affairs Troy Quander said. "This helps mitigate potential delays early in the review process and ensures a more efficient and effective approval process."