Biotest AG: Biotest announces important Milestone for Full Line of Manual Blood Bank Reagents
Biotest AG / Miscellaneous
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Biotest announces important Milestone for Full Line of Manual Blood Bank
Reagents
Denville, NJ / Dreieich, 20 October 2006. Biotest Diagnostics Corporation
(BDC), subsidiary of Biotest AG, a worldwide supplier of manual and
automated solutions to the blood bank industry, announced today that it has
made Biologic License Applications and 510(k) premarket notification
submissions to the U.S. Food and Drug Administration (FDA) for a full line
of Manual Blood Bank Reagents. The reagent line will provide laboratories
another choice in blood group serology reagent suppliers. Biotest is
previewing the new blood bank product line in addition to its TANGO®
Automated Blood Bank System, at the AABB Annual 2006 meeting in Miami on
October 21-24.
The new line of blood bank reagents will include ABO and Rh antisera,
Anti-Human Globulin reagents, potentiators, and quality control products.
The Reagent Red Blood Cell products will include three configurations for
antibody screening, antibody identification panels, Coombs control cells,
and reverse ABO products. Rare antisera 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 United
States.
The parent company for BDC, Biotest AG, has been manufacturing blood group
serology reagents since 1949 with the introduction of the first anti-D
reagent in Europe. Additionally Biotest AG introduced the first monoclonal
line sold under the trade name SERACLONE® in 1983. On May 12, 2006,
Biotest’s Manual Blood Bank Reagent line received clearance from Health
Canada and is currently being offered to blood banks throughout Canada.
“This is a significant milestone, not only for Biotest, but also for the
transfusion medicine industry,” said Bill Weiss, President for Biotest
Diagnostic Corporation. “The addition of more blood bank reagent suppliers
will strengthen the security of the industry and will offer transfusion
medicine specialists new choices. There is already substantial demand for
new entrants into this market.”
Field trials have been completed and the 510(k) premarket notifications
submissions and Biologic License Applications have been submitted to the
U.S. Food and Drug Administration. U.S. market release is anticipated in
2007.
About Biotest
Biotest AG, Dreieich, Germany, is a company that researches and
manufactures pharmaceutical, biotherapeutic and diagnostic products and has
specialised in immunology and haematology. In its Pharmaceutical segment,
Biotest develops immunoglobulines, clotting factors and albumins based on
human blood plasma. These are used for diseases of the immune system or
haematopoietic system. In addition, Biotest also researches into the
clinical development of monoclonal antibodies, including in the indications
of rheumatoid arthritis and blood cancer. The Diagnostic segment spans
reagents and serology and microbiology systems which are used, for example,
in blood transfusions. Biotest has around 1,100 employees worldwide and its
shares are listed in the Frankfurt Stock Exchange's Prime Standard.
Biotest AG: Dr. Michael Ramroth, Telefon: +49 (0) 6103 801-338
Telefax: +49 (0) 6103 801-347, E-Mail: michael.ramroth@biotest.de
Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de
German Securities Code Number, ISIN ordinary shares: 522720, DE0005227201
German Securities Code Number, ISIN preferred shares: 522723, DE0005227235
Listed: Prime Standard/Official market
Frankfurt, Berlin, Düsseldorf, Hamburg, Stuttgart
DGAP 20.10.2006
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Language: English
Issuer: Biotest AG
Landsteinerstr. 5
63303 Dreieich Deutschland
Phone: +49 - 6103 / 801 - 0
Fax: +49 - 6103 / 801 - 150
E-mail: mail@biotest.de
WWW: www.biotest.de
ISIN: DE0005227201, DE0005227235
WKN: 522720, 522723
Indices:
Listed: Amtlicher Markt in Frankfurt (Prime Standard); Freiverkehr in
Berlin-Bremen, Düsseldorf, Hamburg, Stuttgart
End of News DGAP News-Service
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