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PrognostiX
Biotech Specialty Pharma
10265 Carnegie Avenue
Cleveland, OH 44106 USA
phone:216-445-7469
fax:866-449-0960
Symbol Private
Founded 2004
Employees 13
www.prognostix.com
Research Sector Biotech Specialty Pharma
Summary Description
Molecular Biomarker Technologies and Diagnostics for Cardiovascular and Immunological Applications
Management
Jake Orville, President and CEO; Shaohong Liang, M.D., Director, Monoclonal Antibody and Assay Development Laboratory; Weijia Wu, Ph.D., Director, Product Development and Reference Laboratory; Scott F. Purvis, Director, Operations; Rachele Rhea, Manager, Customer Support
Keywords
Cardiology, Diagnostics, Immunology. Molecular Biomarkers, Inflammation, Assay

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Updated: Mar. 22, 2011

Description
PrognostiX is a specialty diagnostics company and reference laboratory focused on molecular biomarker technologies and the creation or proprietary diagnostic tests that address critical unmet needs in patient care. The company was spun out of the Cleveland Clinic to develop and rapidly commercialize unique diagnostic technologies with applications in cardiovascular and inflammatory indications.
Products / Services
CardioMPO is an enzyme immunoassay intended for the quantitative determination of myeloperoxidase in human plasma, to be used in conjunction with clinical history, ECG and cardiac biomarkers in evaluating patients with chest pain that are at risk for major adverse cardiac events, including myocardial infarction. The CardioMPO Assay is comprised of the CardioMPO Reagent Kit, the CardioMPO Calibrator Kit, and the CardioMPO Control Kit. PrognostiX's proprietary product pipeline also includes valuable, high-margin cardiovascular and inflammatory biomarkers licensed to the company exclusively by the Cleveland Clinic. Among these pipeline products is a novel biomarker that complements the cholesterol test, providing additional, more precise information for coronary artery disease risk assessment. The company also operates a CLIA-certified and CAP-accredited specialty reference laboratory, enabling it to bring promising new cardiovascular biomarkers to market more quickly and to serve selected clinical laboratories, investigators, companies, and research institutions with an interest in cardiovascular and inflammatory diseases.
Technology / Differentiation
The CardioMPO Assay is a sandwich enzyme-linked immunosorbent assay (ELISA) that uses two highly specific monoclonal antibodies for the measurement of MPO concentration in human lithium heparin plasma. MPO, an enzyme that is synthesized and stored within polymorphonuclear leukocytes (PMN's) and monocytes, generates an array of reactive oxidants and free radical species as part of its role in host defenses. These same reactive species can inflict oxidative damage on biological targets, including lipids and protein, and are enriched within human atherosclerotic plaques. MPO levels have been shown to be an independent predictor of endothelial dysfunction, angiographically evident CAD, and incident cardiac risks in subjects.
Market / Customers
The company's customers include hospitals, cardiologists, emergency rooms, reference labs and physicians' offices.
Status
PrognostiX has a significant pipeline of assays that are protected by intellectual property and target large, under-addressed markets. The company has achieved annual revenue of approximately $1.4 million and is now seeking funding to solidify its biomarker franchise and launch a more comprehensive disease management program. Prognostix announced that it has entered into a distribution agreement with Inverness Medical Innovations, under which Inverness will distribute PrognostiX's CardioMPO Test through its global sales and distribution infrastructure.