GT Signs Manufacturing Contract with ZEUS Scientific
Gamma Therapeutics Signs ELISA Immunoassay Manufacturing
Contract with New Jersey-Based ZEUS Scientific
ZEUS offers a product menu of over 130 FDA cleared immunoassays across three technology platforms
January 31, 2012—Portland, Oregon/Branchburg, New Jersey–Gamma Therapeutics, Inc., an Oregon early stage biotechnology venture developing cardiovascular disease diagnostic tests, surgical therapy and military medicine solutions, announced today that it has signed a manufacturing contract with New Jersey-based ZEUS Scientific, Inc., one of the world’s leading manufacturers of autoimmune and infectious disease immunoassay kits and products for the clinical diagnostic industry. Initially, ZEUS will manufacture prototype 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. Longer term, ZEUS will be the preferred manufacturer for the Company’s assay kit product line. The GammaCoeur assay will be tested at selected beta test sites in the United States starting winter, 2012.
According to Scott J. Tourville, ZEUS Scientific’s President, “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. We 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 their at-risk patients.”
First GammaCoeur CVD Risk Assay Planned on ELISA Platform. Mainstream consumer clinical diagnostic laboratories provide testing on a diversity of immunoassay platforms, including enzyme-linked immunosorbent assays (ELISA), microbead turbidimetric and lateral flow, to name a few. Gamma Therapeutics chose the ELISA format because it is the most commonly used assay in clinical diagnostic and research labs. ELISA kits are manufactured and tested on manual, semi-automated and automated platforms. However, automated platforms are more common and the first selected platform for the GammaCoeur assay. Once cleared by the FDA and employed in clinical diagnostic lab tests, the GammaCoeur assay will provide physicians with a cardiac risk score that complements other traditional cardiac biomarkers and will assist them in their prognosis and patient management. New health care reform laws place a higher premium on diagnostic testing and preventative care medicine to avoid costly long term drug treatment regimens and invasive cardiac surgery. Gamma Therapeutics supports this initiative.
“On behalf of Dr. David H. Farrell, our Founder and Chief Scientific Officer, Gamma Therapeutics looks forward to a long and mutually beneficial relationship with its new manufacturing partner, ZEUS Scientific. One aspect that makes the relationship particularly appealing to the company is the global nature of ZEUS’s business, its vast product portfolio, its distribution network and its long-term experience in bringing highly successful and profitable immunoassays to market, “ commented David F. Eastman, chief executive officer.
About Gamma Therapeutics, Inc.
Gamma Therapeutics is an early stage biotechnology venture developing several patented and patent-pending products including the GammaCoeur™ CVD Risk Assay for diagnostic testing of cardiac at-risk patients; the Gammarin™ Anticoagulant Blood Thinner for control of venous thromboembolism during and after surgery; the GammaSeal™ Surgical Incision and Wound Closure Sealant for trauma surgery, wound repair and tissue regeneration; and, the GammaTF™ Warfighter Hemostatic Dressing for fast clotting of massively bleeding wounds and injuries. All Gamma Therapeutics’s products are based upon human compatible proteins responsible for the clotting mechanism in blood. Gamma Therapeutics’s corporate offices and laboratory are headquartered at 2611 SW Third Avenue, Suite 280N, Portland, Oregon 97201 USA. For more information visit: www.gamma-therapeutics.com
About ZEUS Scientific
ZEUS Scientific has over 35 years of experience in developing, manufacturing and marketing in vitro diagnostic laboratory tests. No other company offers the breadth and depth of products across both autoimmune disease and infectious serology testing, across three methodologies: IFA, ELISA and multiplex (AtheNA Multi-Lyte®). ZEUS Scientific is based in Branchburg, New Jersey and markets test systems around the globe through an extensive distribution network. ZEUS Scientific complies with the international standard ISO 13485 (2003), Health Canada Medical Device Regulations (SOR/98-282, May 7 1998), the FDA Quality System Regulations (FDA Quality System Regulation, 1996: 21 CFR § 820), and the IVD 98/79/EEC. For more information visit: www.zeusscientific.com.
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™GammaSeal, GammaCoeur, Gammarin, and GammaTF, the products and brands, and Gamma Therapeutics, the company name and logo, are trademarks of GammaTherapeutics, Inc., Portland, Oregon. All Rights Reserved ©Copyright, 2012
™ZEUS IFA, ZEUS ELISA and the company name and logo are trademarks of ZEUS Scientific, Inc., Branchburg, New Jersey, All Rights Reserved © Copyright 2012
®AtheNA Multi-Lyte is a registered trademark of ZEUS Scientific, Inc. Branchburg, NJ
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