US-based early stage biotechnology venture Gamma Therapeutics has signed a manufacturing contract with Zeus Scientific, a manufacturer of autoimmune and infectious disease immunoassay kits and products for the clinical diagnostic industry.
Under the agreement, Zeus will develop prototype enzyme-linked immunosorbent assay (ELISA) kits for use in beta testing of Gamma Therapeutics’s GammaCoeur cardiovascular disease (CVD) risk assay, 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.
The GammaCoeur assay will provide clinicians with a cardiac risk score that complements other traditional cardiac biomarkers and will assist them in patient prognosis and management.
ELISA kits are manufactured and tested on manual, semi-automated and automated platforms, and are the most commonly used assay in clinical diagnostic and research laboratories. Zeus Scientific president Scott Tourville said they look forward to partnering 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 at-risk patients.
"Zeus prides itself on developing innovative and best-in-class products that allow our customers in the global clinical diagnostic market to provide rapid, high quality and accurate testing,” Tourville added.
Gamma Therapeutics chief executive officer David Eastman said the partnership deal with its new manufacturing partner Zeus Scientific makes the relationship appealing to the company with its vast product portfolio, distribution network and long-term experience in bringing highly successful and profitable immunoassays to market.
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The GammaCoeur assay will be tested at selected beta test sites in the US starting in winter, 2012, the company said.
Gamma Therapeutics is focused on developing patented and patent-pending products such as GammaCoeur CVD risk assay for diagnostic testing of cardiac at-risk patients, the Gammarin anticoagulant blood thinner for control of venous thromboembolism, the GammaSeal surgical incision and wound closure sealant and the GammaTF warfighter hemostatic dressing for fast clotting of massively bleeding wounds and injuries.
Image: Zeus Scientific has joined Gamma Therapeutics to develop cardiac biomarker assay kits. Photo: Jeffrey M. Vinocur.