MONTVALE, N.J., Nov. 19 /PRNewswire-FirstCall/ -- Synvista Therapeutics, Inc. (AMEX: SYI) today announced that it has submitted, and that the FDA has received its application for 510(k) clearance for its HAPTOCHEK(TM) diagnostic test kit. The 510(k) submission begins a 90-day review process, during which the FDA will determine whether the kit can be distributed to labs throughout the country as an in vitro diagnostic.
"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," said Noah Berkowitz, M.D., President and CEO of Synvista Therapeutics. "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."
About Synvista Therapeutics
Synvista Therapeutics is a biopharmaceutical company developing clinical diagnostic laboratory tests and drugs to diagnose, treat and prevent cardiovascular disease in people with diabetes. The Company has developed a protein-based clinical laboratory test to identify patients with Hp2-2 diabetes. 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. The Company is also developing a kit to measure CML (carboxy-methyllysine), another potential cardiovascular risk marker.
Synvista Therapeutics is developing oral antioxidant drugs to treat the HDL dysfunction seen in Hp2-2 diabetes, a disease affecting almost 7 million patients in the United States. The Company is also developing alagebrium, a proposed breaker of advanced glycation endprodu
|SOURCE Synvista Therapeutics, Inc.|
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