To: Daniel Schumacher who wrote (365 ) 4/14/1998 10:29:00 AM From: Billie Thon Read Replies (1) | Respond to of 507
Tuesday April 14, 6:34 am Eastern Time Company Press Release Biopool International Receives FDA Approval to Market a New Blood Screening Product VENTURA, Calif.--(BW HealthWire)--April 14, 1998--Biopool International Inc. (Nasdaq:BIPL - news) Tuesday announced that the company's BCA Division has received Food and Drug Administration approval to market a new screening product for use in hospital blood banks and commercial reference laboratories. The new product is a fetal screening test for the detection of D(Rh) positive red cells in D negative maternal samples. The Fetal D Tection Kit is composed of Indicator Cells, Positive and Negative Control Cells, a specially formulated Chemically Modified Anti-D Reagent in a customized diluent and Counting Chamber Slides. When D negative women deliver D positive infants, maternal sensitization to the D antigen of the infants can be avoided by the timely administration of an intramuscular injection of Rh immune globulin (Rhig). Failure to determine the correct dosage of Rhig may result in the women being sensitized to the D antigen and may cause serious consequences in future pregnancies. The Fetal D Tection Kit is a fast, simple qualitative test for screening maternal samples to identify those who may require a more quantitative test to determine the correct dosage of Rhig to protect the mother. Michael D. Bick, Ph.D., chairman and chief executive officer of Biopool, stated: ''The Fetal D Tection Kit offers some significant advantages over other kits on the market. The addition of the Counting Chamber Slides adds uniformity to the test procedure by providing a mechanism to more accurately count the number of fetal cells present in the maternal sample. ''The Counting Chambers are comprised of a gridded area of 9 fields consisting of 9 squares per field. The maternal sample is added by a pipette and filled by capillary action. The technologist then microscopically reads the results in the grid area. Current kits on the market do not offer the uniform sample volume or the consistent reading area of the grid.'' Bick added: ''The launch of this new kit further strengthens our position in the market and adds to our already comprehensive product line. Additionally, it replaces a kit marketed under another company's name and significantly contributes to the profitability of the product line.'' 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. NOTE: This news release contains forward-looking statements regarding future market position and product line profitability that 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 Inc., Ventura Michael D. Bick or Carol Hill, 805/654-0643 More Quotes and News: BIOPOOL INTL (Nasdaq:BIPL - news) Related News Categories: biotech, medical/pharmaceutical