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Biotest Diagnostics Corporation Receives FDA Clearance for Full Line of Traditional Blood Bank Reagents


8/18/2008 7:17:39 AM

ROCKAWAY, N.J., Aug. 18 /PRNewswire/ -- Biotest Diagnostics Corporation (Biotest) -- the U.S. subsidiary of German-based Biotest AG, a worldwide supplier of traditional and automated blood bank solutions -- announces that it has received final clearance from the U.S. Food and Drug Administration (FDA) to begin marketing its full line of traditional blood bank reagents in North America. Intended for use by donor centers, reference laboratories and hospitals for blood group serology testing, these traditional blood bank reagents complement Biotest's existing portfolio of automated reagents that work with its TANGO|optimo Automated Blood Bank System. The availability of these additional reagents afford customers more comprehensive, cost-effective choices -- marking a major milestone for Biotest and the transfusion medicine industry.

"The ability to efficiently and accurately screen and type blood, as well as match patients and donors is critical, as are the tools we provide the blood banking industry," said Bill Weiss, president, Biotest. "The approval of our traditional reagent line provides laboratory professionals with a vital alternative for their testing needs. Accessibility to more options at competitive prices is a significant offering in today's competitive market. And, as a full-service supplier for laboratories' complete blood typing and testing needs, Biotest is not only helping to strengthen the industry, but is also solidifying its unyielding commitment to customers and their patients."

The traditional reagents that received FDA clearance include: -- Seraclone® Blood Grouping Reagents -- Biotestcell® Reagent Red Blood Cells -- Rare Typing Reagents -- Anti-Human Globulins -- Enhancement Reagents -- Control Sera and Red Cells

Biotest's Reagent Red Blood Cell products include three configurations for antibody screening, two antibody identification panels, Coombs control cells and reverse ABO products. Rare typing reagents will include anti-C, anti-E, anti-c, anti-e, anti-Lea, anti-K, anti-k, anti-Fya, anti-Jka, anti-Jkb, anti-M, anti-N, anti-S, anti-s and anti-P1. All antisera are monoclonal and many of the clones have never been previously available in the U.S. Biotest's reagents are recognized for their high levels of sensitivity and specificity and are competitively priced.

Supporting its reagents and the TANGO|optimo, which features a newly expanded test menu that recently received FDA clearance, Biotest provides a 24/7 tech support hotline to ensure that its customers receive fast and knowledgeable answers to their questions. Biotest's specially trained blood bank field staff -- comprised of medical technologists with donor center and hospital transfusion service experience, and field service engineers with years of diagnostic industry experience -- are on call and available to support implementation that is customized to meet the individual facility's needs and provide fast and effective on-site troubleshooting.

About Biotest

Biotest AG along with its U.S. subsidiary, Biotest Diagnostics Corporation located in Rockaway, N.J., are expecting to strengthen their leadership position in the transfusion diagnostic market with the U.S. introduction of a complete line of traditional and automated serology products for use in blood banks and transfusion services. Biotest AG is a global healthcare company focused on test systems for transfusion and transplant diagnostics as well as clinical immunoglobulin preparations, blood coagulation factors, and environment monitoring. Biotest AG introduced the first test serum for Anti-D -- used to determine the Rh factor -- in 1948 and today is represented in 130 countries with products sold worldwide. For more information about Biotest's blood typing and testing solutions, call 800-522-0090, e-mail info@biotestusa.com or visit Biotest at www.biotestusa.com.

Source: Biotest Diagnostics Corporation


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