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RNS - Biotest AG: Biotest receives approval for TANGO reagents in US

Company: Biotest AG Date: 2005-07-28 Language: English Register to download

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 News Details

Corporate | 28 July 2005 14:33

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Biotest AG: Biotest receives approval for TANGO reagents in US

Corporate-news transmitted by DGAP. The issuer is solely responsible for the content of this announcement. —————————————————————————— Biotest receives approval for TANGO reagents in US Dreieich, July 28, 2005. The U.S. Food and Drug Administration (FDA) issued its approval for test reagents for use in the fully automated TANGO Blood Analysis System on July 27, 2005. The TANGO System 510 (k) has already been cleared in March of this year, and the FDA “Biologic License Application (BLA)” approval means that the last hurdle has been taken prior to the US marketing launch, which is planned for the third quarter of this year. Olympus America Inc., the leading provider of high-throughput automated blood bank instruments to the North American donor market since the 1980s, is responsible for Sales and Marketing of the TANGO System in North America. “The US market launch of TANGO is essential to open up the biggest market of immunhaematology diagnostics in the world. With increasing prices in the last year the market volume for transfusion diagnostics is in a range of 200 millions US dollar currently shared by only two competitors. With Olympus Biotest is convinced to have found a highly competent partner”, said Rolf Vornhagen, managing director of Biotest\`s diagnostic division. In view of the global increase in safety requirements on the diagnostics market, the TANGO System unites state-of-the-art laboratory technology with tried-and-trusted test systems for blood group analyses to form a unique, future-oriented laboratory automation concept. The stringent regulatory requirements of the US market make it one of the world’s most difficult diagnostics markets to enter – and for this very reason the TANGO System, already established on the European market, was further developed and its technology was optimized by Biotest together with Stratec Biomedical Systems AG. The tried-and-trusted, efficient test systems for blood group determination (Erytype) and antibody diagnostics (Solidscreen) were modified and re-configured as a result of the market’s high requirements. The TANGO Analysis System automates blood group and antibody screening. Its standardized method provides a high degree of security when conducting blood- group serum tests. In a 24 hr operation mode, the system replaces complex manual processing and hand-written documentation – thus resulting in faster, lower-cost laboratory processing – with constant high quality results. Information on Biotest AG Biotest AG, Dreieich is a pharmaceutical and diagnostics company with approximately 1,000 employees world-wide. Biotest is specialized in the development, production and marketing of therapeutic and diagnostic systems with a focus on clinical immunology, autoimmune disease, haematology and intensive care medicine. The product portfolio includes human plasma derivatives such as immunoglobulin preparations and blood coagulation factors as well as test systems for transplant and transfusion diagnosis and tests for hygiene monitoring. In addition to further innovative plasma derivatives, Biotest’s therapeutic pipeline comprises several monoclonal antibody candidates. Biotest AG’s shares are admitted to Prime Standard trading on the Frankfurt Stock Exchange. Investor Relations: Hubert Bötsch, Telephone: +49 (0) 6103 801-444, Dreieich, July 1, 2005. +49(0)6103/801-880, E-mail: hubert\_boetsch@biotest.de Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, http://www.biotest.de WKN (German Securities Code), ISIN ordinary shares: 522720, DE0005227201 WKN (German Securities Code), ISIN preferred shares: 522723, DE0005227235 Listed: Official trading in Frankfurt (Prime Standard); OTC in Berlin-Bremen, Düsseldorf, Hamburg and Stuttgart End of announcement (c)DGAP 28.07.2005 —————————————————————————— WKN: 522720; ISIN: DE0005227201; Index: Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin- Bremen, Düsseldorf, Hamburg und Stuttgart 281433 Jul 05