EAST WALPOLE, Mass., April 22 /PRNewswire/ -- Bayer Diagnostics announced
today that its branched DNA (bDNA) Quantiplex HIV-1 RNA 3.0 assay has received
approval from both the French Agence de Medicament (ADM) and the Australian
Therapeutic Goods Administration (TGA) for in vitro diagnostic use. This test
is available for research use in the U. S. and in other countries throughout
the world, though Bayer recently initiated the Premarket Approval Application
(PMA) process with the United States Food and Drug Administration.
"Approval of HIV 3.0 by sophisticated regulatory agencies such as the
Agence de Medicament and the TGA is tremendous news," said Mickey Urdea,
Senior Vice President, Nucleic Acid Testing. "This not only validates the new,
highly sensitive bDNA technology but will ensure that more HIV patients will
have access to advanced viral load testing technology."
Viral load measurement enables researchers to evaluate disease progression
and assess candidate therapies for disease treatment. The Quantiplex HIV-1 RNA
3.0 Assay (bDNA) offers improved analytical sensitivity, quantifying as little
as 50 copies/mL and a broad dynamic range (50 to 500,000 copies/mL) that
eliminates the need for costly reflex testing. Another unique feature of the
test is the ability to accurately quantify across HIV-1 subtypes A-F, ensuring
greater confidence in results.
The Quantiplex HIV-1 RNA 3.0 Assay (bDNA) runs on the Quantiplex(R) 340
Automated bDNA System. With a throughput up to 168 samples per run, this
automated system increases laboratory efficiencies for both high- and low-
volume laboratories running this assay.
Bayer's Business Group Diagnostics, headquartered in Tarrytown, N.Y.,
(http://www.bayerds.com) is one of the largest diagnostics businesses in the world.
The company serves customers in 100 countries with an offering that includes
diagnostics systems in five key segments: Critical Care Testing, Laboratory
Testing, Point of Care Testing, Nucleic Acid Testing and Self-Testing. Bayer
Diagnostics, in combination with Chiron Diagnostics, has approximately
8,000 employees worldwide with combined 1998 sales of $1.2 billion. Bayer
Diagnostics is a member of the worldwide Bayer Group, a $32 billion chemical
and pharmaceutical company based in Leverkusen, Germany.
SOURCE Bayer Diagnostics
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CONTACT:
Victoria DeMoranville of Bayer Diagnostics,
508-660-4581
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