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| |  Thrombus Precursor Protein (TpP) Diagnostic Test Cleared by FDA COPIAGUE, N.Y. Oct. 29, 1996 -- American Biogenetic Sciences, Inc. (ABS) (Nasdaq: MABXA) announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ABS' Thrombus Precursor Protein (TpP(TM)) test. TpP is an in vitro (non-invasive) diagnostic test for the risk assessment of blood clot formation (thrombosis) and to monitor anticoagulant therapy. ABS' TpP test measures soluble fibrin polymers which have been shown to be elevated in patients at risk of thrombosis. Elevated soluble fibrin polymer levels have been identified with various clinical conditions including myocardial infarction (MI), deep vein thrombosis (DVT), disseminated intravascular coagulation (DIC), and in patients undergoing surgical procedures who are experiencing thrombotic complications. ABS has licensed the TpP test to Abbott Laboratories and F. Hoffmann-La Roche Ltd. for use on their proprietary automated diagnostic systems. Both companies are multi-national and possess a significant market share in the automated instrument segment. Also, ABS recently announced agreements with Gull Laboratories, Inc. that provide for the manufacture of the TpP assay, to be sold in certain formats, directly by both ABS and Gull; and a joint venture with Gull to develop the test for assessment of thrombosis in renal dialysis patients. Further development of TpP as a diagnostic for additional clinical conditions and in other assay formats is anticipated. Through the alliance with Gull, a subsidiary of Fresenius AG, and licensing agreements with Abbott Laboratories and F. Hoffmann-La Roche Ltd., ABS is well-positioned to enter the marketplace with TpP. TpP was developed using ABS' patented Antigen-Free system. This innovative process generates antibodies, of high affinity and specificity, that are difficult or impossible to obtain by conventional systems. "FDA marketing clearance of our TpP test is the most significant milestone thus far for ABS. It marks the emergence of ABS from a research and development organization to a commercial operating company with near-term product sales potential. TpP substantiates our belief that the Antigen-Free system can successfully produce superior products," said Alfred J. Roach, Chairman and Chief Executive Officer. American Biogenetic Sciences, Inc. is a global biopharmaceutical company that conducts research and development from its laboratories in the U.S. and through its Global Scientific Network in the U.S., Europe, Israel and Russia. ABS is currently focused on the discovery and commercialization of products in the fields of cardiovascular medicine and neurobiology. Except for any historical information contained herein, the matters discussed in this press release contain forward-looking statements that involve risks and uncertainties which are described in the Company's SEC reports.
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