American Biogenetic Sciences Inc. on Friday said it has receivedFood and Drug Administration approval to market its firstproduct, a monoclonal antibody-based diagnostic forcardiovascular disease.
The Cadkit uses the company's 45J monoclonal antibody tomeasure levels of fibrinogen in patients' blood. Fibrinogen is aprotein that is a member of the clotting cascade. Elevated levelsof fibrinogen are the second-best predictor of risk of heartattack and stroke, after high blood pressure. Cholesterol levelsare the third-best predictor. Every year, 100 million cholesteroltests are given in the United States, said Henry Nordhoff, ABS'president and chief executive officer.
ABS, based in Notre Dame, Ind., estimates the worldwidemarket for the test at $400 million annually. The test can beused in routine physical examinations of men over 35 andpost-menopausal women, and to monitor fibrinogen levels inheart attack patients receiving clot-dissolving therapy.
The company has signed a letter of intent with Medlabs Ltd., aDublin, Ireland-based diagnostics company, which will marketthe test in Europe. ABS is negotiating with potential U.S.marketing partners.
ABS stock (NASDAQ:MABXA) closed unchanged at $7.63 onFriday.
-- Karen Bernstein BioWorld Staff
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