Premarket Approval Sought for CDx Test to Benefit Lung Cancer Patients

Ventana Medical Systems, Inc. (Tucson, AZ, USA) has announced its US Food & Drug Administration (FDA) final stage submission for premarket approval (PMA) of its companion diagnostic (CDx) immunohistochemistry (IHC) test designed to identify ALK1-positive lung cancer patients that may benefit from treatment with targeted therapy that inhibits the ALK gene.

The submission is for the VENTANA ALK (D5F3) CDx Assay, and is the fourth and final module and application required by the PMA process.


"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," said Doug Ward, Lifecycle Leader, Companion Diagnostics, Ventana Medical Systems.

"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," said Troy Quander, vice president, Regulatory Affairs, Ventana Medical Systems.

Non-small-cell lung cancer (NSCLC) is the most common subtype of lung cancer. About 5% of NSCLC patients have a rearrangement in the gene ALK (anaplastic lymphoma receptor tyrosine kinase). This mutation is most often seen in nonsmokers (or light smokers) who have the adenocarcinoma subtype of NSCLC. The rearrangement produces an abnormal ALK protein that causes the cells to grow and spread. The new VENTANA ALK (D5F3) CDx Assay provides patients and their physicians with a highly efficient, standardized, and cost effective method for assessing ALK protein expression and eligibility for available targeted therapy. IHC testing is widely accessible on VENTANA BenchMark XT instruments.

A drug development program with a CDx strategy may expedite the drug approval process and help generate more effective treatments with improved safety profiles for patients. Ventana has worked with over 45 biopharmaceutical partners and is currently engaged in over 180 collaborative projects to develop and commercialize CDx globally.

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