TARRYTOWN, N.Y., March 30 /PRNewswire/ -- Chiron Diagnostics, a business
unit of Bayer Diagnostics, announced today that they have initiated the
Premarket Approval Application (PMA) process for the Quantiplex(R) HIV-1 RNA
3.0 Assay (bDNA). The test incorporates third generation branched DNA (bDNA)
technology for highly sensitive quantitation of HIV-1 viral load in human
plasma. The test is already approved for in vitro use in France and
Australia.
On March 5, the company completed and submitted the first PMA module
associated with this process. It is anticipated this modular approach to the
PMA submission process should accelerate the product's review and approval
cycle. "As the array of anti-viral therapies continues to increase, so too
does the need for highly sensitive viral load measurements," said Mickey
Urdea, Senior Vice President, Nucleic Acid Diagnostics. "We believe that our
data will clearly demonstrate that the performance of this test will
positively impact the physician's ability to monitor disease treatment in HIV
patients."
The Quantiplex HIV-1 RNA 3.0 assay is an automated test; and the assay's
broad dynamic range (50 to 500,000 copies/mL) allows for measurement at
physiological levels of the virus as well as eliminates the need for reflex
testing. In addition, the test is capable of accurately quantifying as little
as 50 copies of HIV-1 -- subtypes A-F -- in 1 mL of plasma.
Recent studies indicate that there is a growing incidence of HIV-1 non B
subtypes in the U.S., particularly in urban environments. Because an
individual's HIV-1 subtype is rarely known, it is critical that viral load
assays accurately measure HIV-1 regardless of subtype. Several studies report
bDNA's ability to accurately quantify HIV-1 subtypes A-F, in contrast to some
tests using other technologies, which are reported to be unable to detect
subtype A and may underestimate viral load for HIV-1 E and F. One such
article was presented recently at the Association of Public Health
Laboratories in Albuquerque, NM, by Mehsen Joseph, PhD of the Maryland State
Department of Public Health in Baltimore, MD. In that article he reported,
"The ultra sensitive bDNA assay produced considerably higher HIV-1 viral load
results in comparison to results from other viral load technologies when
testing this group of non-clade B HIV-1 infected patients. The bDNA results
will allow clinicians to make more informed treatment decisions and to more
accurately monitor HIV disease progression for these patients."
The Quantiplex HIV-1 RNA 3.0 assay runs on the Chiron Quantiplex 340
Automated bDNA System. The system has a throughput of 12-168 samples per run,
thereby reducing labor requirements and increasing laboratory efficiencies.
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 three key segments: Laboratory Testing, Point-of-Care
Testing and Self-Testing. Bayer Diagnostics has approximately 8,000 employees
worldwide with combined 1997 sales of close to $1.7 billion. Bayer
Diagnostics is a member of the worldwide Bayer Group, a $31 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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