American Biogenetic Sciences Inc. (ABS) of Notre Dame, Ind.,said Thursday it filed for marketing approval for what couldbecome its first product: a monoclonal antibody-based test formeasuring fibrinogen levels in blood plasma.
High levels of fibrinogen have been shown to indicate a highrisk of heart disease. Fibrinogen is the precursor of fibrin,which is the primary component of blood clots.
Barring an unforeseen glitch before the Food and DrugAdministration, the test kit, trade named Cadkit, should reachthe market within three months, said Henry Nordhoff, ABS'president. ABS estimates that the potential annual market for akit to diagnose predisposition to heart disease and to monitorfibrinogen levels during therapy to dissolve blood clots couldbe $400 million.
Cadkit is a latex agglutination assay based on a monoclonalantibody (MAb) that targets a specific portion of fibrinogen.ABS is also developing a fibrin-specific MAb as a means todirect thrombolytic agents to clots. It hopes that the samefibrin-specific MAb for imaging blood clots will enter humantrials this year.
ABS raised $6 million in an initial public stock offering lastMay, selling 1 million units (NASDAQ:MABXU) at $6 each ofcommon stock and warrants. -- Carol Ezzell
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