Biopool International Receives FDA Clearance to Market Anti-D Blood Grouping Reagent.VENTURA, Calif.--(BW HealthWire)--Jan. 19, 1999--Biopool International Inc. (Nasdaq:BIPL BIPL Biphase Level ) Tuesday announced that the company's BCA BCA Business Case Analysis BCA Building Code of Australia BCA Boeing Commercial Airplanes BCA Board of Contract Appeals BCA Boston Center for the Arts BCA Billiard Congress of America BCA Bureau of Criminal Apprehension BCA Breast Cancer Action Division has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clearance to market a monoclonal antibody-based Anti-D blood grouping blood grouping n. The process of identifying an individual's blood group by serologic testing of a sample of blood. Also called blood typing. reagent. This new product is a combination of human monoclonal and human polyclonal antibodies, which is adaptive to all common test procedures used in the blood bank laboratory, including slide, tube and micro-plate procedures. In independent studies, the new BCA reagent compared favorably with competitive products, especially with respect to the detection of weak antigens. The "D" antigen is the most important of the Rh blood group system, such that Anti-D testing is mandatory for all pre-transfusion blood donors and recipients. The commonly used terms "Rh positive" and "Rh negative" refer specifically to the presence or absence of the D antigen. In transfusion medicine transfusion medicine Blood banking A subspecialty of clinical pathology or internal medicine which is involved in Pt management through administration of blood cells and blood products including fresh-frozen plasma and cryoprecipitate; TM specialists are versant in , the status of the D antigen must be compatible between donor and recipient to prevent a life-threatening hemolytic transfusion reaction hemolytic transfusion reaction Transfusion medicine A therapy-related event mediated by 2 different mechanisms: 1. Intravascular hemolysis mediated by complement-fixing antibodies, 2. . Thus, Anti-D testing is performed in hospitals as well as all blood donor centers. Further, the status of the D antigen must be established in all pregnant women to prevent complications in future pregnancies. Once the D status has been established, therapeutic regimens can then be initiated. Michael D. Bick, Ph.D., chairman and chief executive officer of Biopool, stated: "The D antigen test is one of the most frequent tests performed in the blood bank laboratory. Anti-D testing is not new to Biopool/BCA; we previously distributed an Anti-D product under a competitor's brand name to round out and complete our product offering to blood bank laboratories. Now, however, we will be able to market a high-quality Biopool/BCA branded product at a substantially improved cost structure." Founded in 1987, Biopool International develops, manufactures, and markets a full range of test kits to assess and diagnose disorders of blood coagulation, thrombotic risk factors, fibrinolysis fibrinolysis /fi·bri·nol·y·sis/ (fi?brin-ol´i-sis) dissolution of fibrin by enzymatic action.fibrinolyt´ic fi·bri·nol·y·sis n. pl. , platelet function, and the vascular system; specialty chemistry controls used to monitor and measure the presence of drugs of abuse; and blood group serology Serology The division of biological science concerned with antigen-antibody reactions in serum. It properly encompasses any of these reactions, but is often used in a limited sense to denote laboratory diagnostic tests, especially for syphilis. products used to screen for antibodies and group and type whole blood. The company's product line of more than 150 FDA-approved products is sold to hospitals, blood bank facilities, and clinical and reference laboratories on a worldwide basis by the company's own sales representatives, as well as through an extensive network of distributors. To learn more about Biopool, visit the company's Web site at http://www.biopool.com. NOTE: This news release contains forward-looking statements regarding product cost structure which are based upon current expectations that involve a number of risks and uncertainties including, but not limited to, technological innovations of competitors, changes in health care regulations, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. claims, foreign currency fluctuation, product acceptance or changes in government regulation of the company's products, as well as other factors discussed in the company's last report on form 10-K-SB under "Risk Factors." |
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