Under a $1.1 million Phase II Small Business Innovation Research grant from the National Heart, Lung and Blood Institute (NHLBI), Gamma Therapeutics will complete development, validation and beta testing for its GammaCoeur CVD risk assay.
According to Portland, Ore.-based Gamma Therapeutics, the grant will allow the company to submit a regulatory approval application for the Class II in vitro diagnostic device to the FDA.
The company said that GammaCoeur reiterates the need for a MI and stroke risk biomarker for diagnostic tests used to record cholesterol, triglycerides and glucose levels. GammaCoeur, when approved, will provide cardiologists with a better tool for predicting a patient’s MI risk, according to the company.
Gamma Therapeutics, a diagnostic test and surgical therapy solutions developer, said that it expects the FDA regulatory approval process to take up to two years, and said it expects approval by the end of 2012.