Biotest AG: New Automated Assays for TANGO® Automated Blood Bank Systems under Food and Drug Administration Review
Biotest AG / Miscellaneous
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New Automated Assays for TANGO® Automated Blood Bank Systems under Food and
Drug Administration Review
Denville, NJ, 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 made Biologic
License Applications and 510(k) premarket notifications to the U. S. Food
and Drug Administration (FDA) for an expanded test menu on its TANGO®
Automated Blood Bank System on September 28, 2006. The TANGO was originally
cleared by the FDA in July 2005 and is marketed in North America to
hospitals through BDC and to donor centers though Olympus. Biotest is
previewing the new expanded automated test menu in addition to its TANGO®
Automated Blood Bank System, at the AABB Annual 2006 meeting in Miami on
October 21-24.
The TANGO System is currently licensed for applications that cover
approximately 80% of the normal test workload in the transfusion service.
Current assays include patient and donor ABO/Rh testing, antibody screening
using three different Reagent Red Blood Cell configurations, and donor ABO
and Rh confirmation testing. The new applications that are currently under
FDA review include antibody identification, Rh phenotyping, K1 phenotyping,
crossmatching, direct antiglobulin testing and a weak D assay.
“Biotest has been very pleased with the initial reception to the TANGO
Automated System. Blood donor centers, hospitals and reference laboratories
alike are realizing the cost-effectiveness, labor savings, ease of use,
flexibility, outstanding reagent management system and process control
associated with the TANGO,” said Candace Williams, Vice President for
Transfusion Diagnostics for BDC. “Once the TANGO test menu expansion
obtains regulatory licensure and clearance, the TANGO System will provide
even more value to blood bank facilities.”
Field trials have been completed and the 510(k) premarket notification
submissions and Biologic License Applications have been submitted to the
U.S. Food and Drug Administration. U.S. market release is anticipated in
2007. The expanded TANGO test menu product line is currently available in
Europe through Biotest AG, the manufacturer of the system.
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: Tel. +49 6103 801-338
Fax: +49 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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