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Biotech / Medical : Nanogen, Inc. (NGEN)
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To: tuck who wrote (185)10/18/2001 8:00:10 AM
From: nigel bates  Read Replies (1) of 258
 
SAN DIEGO, Oct. 18 /PRNewswire/ -- Nanogen, Inc. (Nasdaq: NGEN - news) announced today that it has completed internal validation of a DNA-based protocol for Factor II 20210 Mutation (Prothrombin), a key marker in the detection and risk assessment of certain cardiovascular disorders characterized by blood clot formation (thrombosis). The anticipated users for the protocol include CLIA (Clinical Laboratory Improvement Act) certified laboratories who will have the option to further develop and validate this protocol for internal use in a ``home-brew'' format.
The company has now internally validated DNA protocols for both Factor II and Factor V Leiden for use in academic and other research laboratories on the NanoChip® Molecular Biology Workstation. Both protocols detect key genetic markers in the blood of patients who are at risk of developing clinical thrombosis. Clinical thrombosis can lead to heart attacks or stroke. Nanogen is also developing additional protocols designed to help researchers identify genetic links in illnesses that may lead to improved treatment and prevention decisions made in patient care.
``The introduction of the Factor II protocol represents another important step in Nanogen's planned entry into the clinical diagnostics market,'' said Howard C. Birndorf, Executive Chairman and Founder of Nanogen. ``We believe that providing a suite of protocols relating to a specific disease, in this case cardiovascular disease, will increase the value and acceptance of the NanoChip® System throughout the life sciences industry. We intend to continue to pursue regulatory clearance or approval of molecular diagnostic tests utilizing the NanoChip® System.''
According to the American Heart Association 2001 Heart and Stroke Statistical Update, 60.8 million Americans have some form of cardiovascular disease. Mutations in the Factor II gene (Factor II, Prothrombin) and Factor V gene (Factor V Leiden) are the most common causes of hereditary blood coagulation disorders that can lead to cardiovascular disease. The Factor II and Factor V Leiden mutations are present in two to three percent and three to seven percent of the population in Europe and the United States, respectively. Carriers of the Factor II mutation have a three to eight fold increased risk for blood clot formation, and the risk is significantly greater in those who also carry the Factor V Leiden mutation...
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