Ventana Medical Systems, Inc. has filed a submission with the U.S. Food and Drug Administration (FDA) requesting the premarket approval (PMA) of a diagnostic test to identify anapestic lymphoma receptor tyrosine kinase (ALK) positive lung cancer. The test, called theVENTANA ALK (D5F3) Cdx Assay, is expected to improve early diagnosis in order to provide better treatment, if the agency approves the submission, according to the company’s press release.
The VENTANA ALK (D5F3) Cdx Assay is a diagnostic (Cdx) immunohistochemistry (IHC) test developed by Ventana for patients who are thought to potentially need treatment with targeted therapy that inhibits the ALK gene. Therefore, the company intends to commercialize the test with the approval of the submission, which is already the fourth and final FDA requirement of 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,” explained the Lifecycle Leader for Companion Diagnostics, Ventana Medical Systems, Inc., Doug Ward. “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.”
Non-small cell lung cancer is the most typical subtype of the disease, which is the leading cause of death associated with cancer in the world. In addition, approximately 5% of the patients carry the ALK gene, particularly non-smokers, who suffer from the adenocarcinoma subtype of NSCLC. The ALK gene rearrangement is responsible for an abnormal protein that provokes the growth and spread of cancer cells.
Therefore, the VENTANA ALK (D5F3) CDx Assay works by offering patients and physicians an efficient, standardized, and cost effective testing method able to evaluate the expression of the ALK protein, as well as its eligibility for a treatment based on targeted ALK inhibitor.
“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,” added the vice president for regulatory affairs at Ventana Medical Systems, Troy Quander.
Ventana, which is a member of the Roche Group, is dedicated to the development of companion diagnostic tests to improve the detection of specific biomarkers and help physicians in the definition of appropriate therapies. The company collaborates with more than 45 biopharmaceutical partners and is currently focused in more than 180 collaborative projects for the commercialization of companion diagnostics worldwide.
In addition to improve diagnosis and treatment, Ventana believes that by incorporating a companion diagnostic strategy into a drug development program, it might accelerate the process of drug approval, as well as help create more effective therapies with improved safety profiles for patients.