Synvista Therapeutics, Inc Announced on the 18th of November, 2008, that it has applied for FDA clearance for its revolutionary HAPTOCHEK diagnostic test kit
Synvista Therapeutics, Inc. a biopharmaceutical company developing clinical diagnostic laboratory tests and drugs to diagnose, treat and prevent cardiovascular disease in people with diabetes, announced it has submitted an application for 510(k) clearance for its HAPTOCHEKTM diagnostic test kit to the FDA. The 510(k) submission begins a 90-day review process, where the FDA will determine whether the kit can be distributed to labs throughout the country as an in vitro diagnostic.
This revolutionary kit, developed by Prof. Andrew Levy of The Rappaport Institute and his lab, is a protein-based clinical laboratory test to identify patients with Hp2-2 diabetes, a disease affecting almost 7 million patients in the United States. Tests which identify patients with Hp2-2 diabetes may be useful in identifying diabetic patients at high risk for cardiovascular complications. These patients may benefit from a particular formulation of vitamin E.
Noah Berkowitz, MD, President and CEO of Synvista Therapetics stated: "We are very pleased to announce the submission of a 510(k) application for our test kit to the FDA, as it demonstrates that we are continuing to execute on our business plan... We believe that, once cleared by the FDA, our test will become an important facilitator of personalized medicine and may provide a standard by which physicians can influence clinical outcome."