TARRYTOWN, N.Y., May 17 /PRNewswire/ -- Bayer Diagnostics announced today
that it has completed its Premarket Approval Application (PMA) to the U.S.
Food and Drug Administration (FDA) for approval of its viral load test for HIV
-- the Bayer HIV-1 RNA 3.0 Assay (bDNA). This test utilizes proprietary
branched DNA technology (bDNA) to measure viral load levels to assist
physicians in monitoring patients infected with HIV-1.
"This PMA submission brings us a step closer to the worldwide commercial
availability of our bDNA technology for nucleic acid testing (NAT) and marks
Bayer's first NAT submission since our acquisition of Chiron Diagnostics,"
stated Rolf Classon, President of Bayer Diagnostics. "This HIV assay is the
first of many NAT assays we plan to offer physicians and laboratory
professionals to enhance the diagnosis and management of patients suffering
from HIV and other devastating infectious diseases."
The test measures HIV-1 viral RNA levels in plasma via the novel branched
DNA (bDNA) signal amplification technology. Based on published clinical
studies in both Europe and the United States, the bDNA technology is
particularly well suited for detecting the various subtypes of HIV-1. The
most common subtype of HIV-1 in the United States is subtype B; however, a
number of other distinct subtypes of the virus have been identified in
addition to other more unique recombinant forms. The bDNA technology
incorporates dozens of probes targeted at capturing the viral nucleic acid for
detection, and this unique design ensures that viral RNA from all of the major
subtypes can be detected and quantified. Bayer's HIV product is already
approved and available in certain countries outside of the United States.
The level of HIV-1 RNA (viral load) in a patient's blood has been shown to
correlate with the progression of the disease. For patients undergoing
anti-retroviral therapy, frequent monitoring of HIV RNA is recommended for
determining the effectiveness of therapy and the emergence of drug resistance.
Currently, there are more than 1 million people infected with HIV in the
Unites States and more than 33 million worldwide.
Nucleic Acid Testing (NAT)
Nucleic acid tests utilize state-of-the-art technologies that allow
laboratories to assay for the presence of infectious agents (virus or
bacteria) by measuring the amount of the pathogens genetic material (DNA or
RNA) in a patient's blood. Unlike other types of in-vitro diagnostics, which
typically measure the body's response to infection or disease, nucleic acid
tests are a direct measurement of the presence of the pathogen. In addition
to bDNA, other nucleic acid technologies include PCR (polymerase chain
reaction) and TMA(TM) (transcription mediated amplification).*
Bayer is the only company in diagnostics with access to the three leading
NAT technologies -- bDNA, PCR and TMA. According to Doug White,
Vice-President of Marketing for Bayer's Nucleic Acid Diagnostics segment,
"Bayer is in a very unique position in the NAT market. Through our
partnerships and licensing agreements we are not limited to a single
technology and have the freedom to select the most appropriate technology for
delivering solutions to the laboratory and the clinician."
Bayer Diagnostics
With more than 7,500 employees worldwide and 1999 sales of close to
$1.8 billion, Bayer Diagnostics (http://www.bayerdiag.com), based in Tarrytown, New
York, USA, is one of the largest diagnostic businesses in the world. The
organization supports customers in 100 countries through an extensive
portfolio of central laboratory, self-testing, nucleic acid, point of care and
critical care diagnostics systems and services for use in the assessment and
management of health, including the areas of cardiovascular disease, oncology,
virology, women's health and diabetes. Bayer Diagnostics is a part of the
worldwide Bayer Group, a $29 billion international life sciences, polymers and
specialty chemicals group based in Leverkusen, Germany. Bayer Diagnostics'
global headquarters in the United States operates as part of Bayer Corporation
of Pittsburgh, a research-based company with major businesses in health care,
life science and chemicals.
* TMA incorporates proprietary amplification technology of Gen-Probe, Inc.
SOURCE Bayer Diagnostics
 back to top
Related links:
http://www.bayerdiag.com
Company News On-Call:
http://www.prnewswire.com/comp/092575.html or fax,
800-758-5804, ext. 092575
CONTACT:
Andrea Johnston, 914-524-3346, or Matthew
Kratz, 914-524-2541, both of Bayer Diagnostics
|
