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| |  Heart Attack-Detection Breakthrough Reported COPIAQUE, N.Y., Jan. 27, 1997 -- A new blood test recently cleared by the Food and Drug Administration (FDA) -- TpP(TM) (thrombus precursor protein), developed by American Biogenetic Sciences (ABS) Inc. (Nasdaq: MABXA) -- was at least three times more sensitive in a clinical study than commercially available biochemical markers (creatine kinase-MB, and troponins I and T) currently used for diagnosing heart attacks. Equally important, peak plasma concentration of TpP preceded those of other "heart attack markers" by two to four hours in patients with acute myocardial infarction (AMI) arriving at the hospital within six hours of onset of chest pain. Data confirming the clinical superiority of the TpP blood test were presented by Joseph P. Laurino, Ph.D., assistant professor of pathology and laboratory medicine at Brown University's School of Medicine, at an ABS-sponsored convocation in New York City this past weekend of cardiologists, hematologists and pathologists from around the world. "The leading cause of death in the United States is thrombus-induced acute myocardial infarction (AMI), or heart attack," said Dr. Laurino. "Although great strides have been made to reduce the mortality rate from cardiovascular disease, total deaths are now increasing significantly. Chest pain remains the primary, but least specific, symptom of AMI. However, only 1.5 million, or 15 percent, of patients with chest pain who present each year at hospital emergency rooms are actually experiencing a heart attack. "The major limitation of current diagnostic methods for rapidly diagnosing acute myocardial infarction is that they measure the effects of damaged tissue on the function of the heart, rather than detect the precipitating blood clot," continued Dr. Laurino. "Detection of a coronary blood clot is the more important objective when looking for early evidence of an evolving heart attack. In this study, we investigated the utility of the TpP assay, a test that is able to detect the formation of a blood clot, in the diagnosis of 115 patients with acute chest pain syndrome." "Significantly elevated concentrations of TpP were observed upon arrival in 88 percent of the patients diagnosed with a heart attack who arrived at the hospital within six hours of the onset of chest pain," Dr. Laurino said. "Thus, the sensitivity of TpP early in the course of an evolving heart attack is significantly greater than that of commercially available biochemical markers currently used to diagnose heart attacks. Furthermore, the specificity for the detection of a blood clot in patients with conditions associated with the formation of blood clots was nearly 95 percent. While additional clinical trials are necessary, the results of this study suggest that the plasma concentration of thrombus precursor protein (TpP) is a sensitive indicator of active blood clot formation in patients with acute chest pain syndrome," Dr. Laurino concluded. Developed by ABS and cleared by the FDA under a 510(k) designation late last year, TpP (thrombus precursor protein) provides a novel approach in the detection of intravascular thrombosis. The blood test permits early identification of patients experiencing active or incipient thrombosis through quantitative determination of soluble polymeric fibrin complexes, which are immediate precursors of insoluble cross-linked fibrin, the major structural component of blood clots. The human body's production of soluble fibrin complexes is indicative of an active thrombosis. Other tests for determining soluble fibrin levels measure fibrinogen and fibrin degradation products and therefore lack specificity to accurately detect the formation of a blood clot. The TpP assay is an immunochemical test that could be adapted to a variety of different formats including automated immunochemistry and point of care (POC) devices. ABS already has marketing-and-sales agreements in place for its TpP test with three companies: Abbott Laboratories, F. Hoffmann-La Roche Ltd. and Gull Laboratories. Thrombosis is the leading cause of death and morbidity in the developed world and claims 42.1 percent of the more than 2.2 million Americans who die each year. Nearly 59 million Americans have some form of cardiovascular disease, according to the American Heart Association. In the U.S., the costs associated with heart disease have reached over $60 billion annually, two-thirds of which is reimbursed by Medicare. Dr. Joseph P. Laurino is Director of Clinical Chemistry and Toxicology, Memorial Hospital of Rhode Island, and Clinical Assistant Professor of Pathology and Laboratory Medicine, Brown University, and Adjunct Clinical Assistant Professor of Microbiology, University of Rhode Island. Dr. Laurino also is President-elect of the Association of Clinical Scientists and a member of the House of Delegates of the American Association for Clinical Chemistry. He has authored or co-authored scientific articles for such peer-reviewed journals as the journal of Organic Chemistry, Clinical Chemistry, Therapeutic Drug Monitoring, and Annals of Clinical and Laboratory Science. American Biogenetic Sciences Inc. is a biotechnology company focused on discovering and commercializing diagnostic products in the fields of cardiovascular medicine and neurobiology.
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