Corgenix Submits Filing to FDA for Clearance of New Test for Measuring Protein S Deficiency
DENVER, Nov. 10 /PRNewswire/ -- Corgenix Medical Corporation (OTC Bulletin Board: COGX - news) announced the filing of a 510k application with the U.S. Food & Drug Administration (FDA) for clearance to market its new Monoclonal Free Protein S test kit.
Protein S is a protein which plays an important physiological role in the anticoagulant (inhibiting clot formation) system. A Protein S deficiency, either congenital or acquired, may lead to serious thrombotic (blood clots) events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism (blood clots in the lungs). A congenital deficiency of Protein S may have a prevalence as high as 15 to 18 percent in young patients (less than 35 years of age) with a history of thrombosis. Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia and various inflammatory syndromes.
Because the new Corgenix test utilizes a monoclonal antibody specific for Free Protein S, it provides a more specific method for laboratory diagnosis of Protein S deficiency. This technology also offers advantages over other methods as it is performed more rapidly, is less labor intensive and provides improved accuracy for the laboratory diagnosis of Protein S deficiency.
Luis R. Lopez, M.D., chairman and CEO of Corgenix, said, ''The potential of this new test is significant and complements our other clotting disorder products. Together with Corgenix's other vascular disease tests, the Monoclonal Free Protein S Antigen kit provides the physician with a more complete picture for an accurate diagnosis of Protein S deficiency.''
Corgenix Medical Corporation is based in metropolitan Denver and is focused on the development and promotion of specialized diagnostic test kits for vascular diseases, immunological disorders, as well as bone diseases such as osteoporosis and joint diseases such as arthritis. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world.
Statements in this release that are not strictly historical are ''forward-looking'' statements within the meaning of the Private Securities Litigation Reform Act of 1995, and should be considered as subject to various risks and uncertainties that could cause actual results to differ materially from those anticipated.
For more information, contact Chris Wolfe, investor relations coordinator of Corgenix at (303) 457-4345, or Kyle Freeman of Corporate Relations Group at 1-800-444-4980. Corporate Relations Group is a subsidiary of Stratcomm Media, Ltd. (OTC Bulletin Board: SMMM - news).
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