Gamma Therapeutics has entered into manufacturing contract agreement with New Jersey-based Zeus Scientific.
Under the contract, Zeus will manufacture prototype enzyme-linked immunosorbent assays (ELISA) kits for use in beta testing of Gamma Therapeutics’s GammaCoeur cardiovascular disease (CVD) risk assay, which is currently under product development and in the pre-IDE review process at the FDA’s Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety.
Gamma said its GammaCoeu assay will be tested at selected beta test sites in the US starting winter, 2012.
ZEUS Scientific president Scott Tourville said they look forward to partner with Gamma Therapeutics in manufacturing and bringing to market, once cleared by the FDA, a novel cardiac biomarker assay kit to further assist physicians in the testing and prognosis of their at-risk patients.
The GammaCoeur assay, once cleared by the FDA and employed in clinical diagnostic lab tests, will provide physicians with a cardiac risk score and will facilitate them in their prognosis and patient management.