To: Jeff who wrote (3460 ) 1/19/1999 12:05:00 PM From: Nescom Read Replies (2) | Respond to of 15987
BIPL news out- Biopool International Receives FDA Clearance to Market Anti-D Blood Grouping Reagent Business Wire - January 19, 1999 11:46 VENTURA, Calif.--(BW HealthWire)--Jan. 19, 1999--Biopool International Inc. (Nasdaq:BIPL) Tuesday announced that the company's BCA Division has received FDA clearance to market a monoclonal antibody-based Anti-D blood grouping 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, the status of the D antigen must be compatible between donor and recipient to prevent a life-threatening hemolytic transfusion reaction. 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, platelet function, and the vascular system; specialty chemistry controls used to monitor and measure the presence of drugs of abuse; and blood group serology 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 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 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." CONTACT: Biopool International, Ventura Michael D. Bick or Carol Hill, 805/654-0643