Synvista files 510(k) clearance application for Haptochek 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.

Noah Berkowitz, president and CEO of Synvista Therapeutics, said: “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.”