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Roche Receives FDA Clearance for Cobas New More Enhanced Amplicor HIV-1
Monitor Test
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PCR-Based Test Enhances Ability to Measure Viral Loads of HIV Patients;
quantifies HIV subtypes A-G
BASEL, Switzerland, April 11 /PRNewswire/ -- Roche today announced that it
has received clearance from the U.S. Food and Drug Administration (FDA) for
the Cobas Amplicor HIV-1 Monitor Test (version 1.5) an enhanced version of
Roche's polymerase chain reaction (PCR) assay used to measure the amount of
HIV-1 RNA (viral load) present in an infected person's blood.
The Cobas Amplicor HIV-1 Monitor Test (version 1.5) is an automated assay
that amplifies and detects genetic material, allowing for accurate
quantification of even small amounts of viral RNA in the blood. This new test
can measure viral loads as low as 50 copies of HIV-1 RNA per millilitre
(c/mL) of plasma. This level of sensitivity is critical for optimising
treatment strategies, because maintaining an infected patient's viral load
below 50 c/mL (undetectable) has been associated with a more complete and
durable viral suppression. This assay is the automated version of the
Amplicor HIV-1 Monitor Test (version 1.5) that received FDA approval last
year.
The Cobas Amplicor HIV-1 Monitor Test (version 1.5) also has the enhanced
ability to quantify HIV-1 Group M subtypes A-G. While HIV-1 subtype B
continues to predominate in Western Countries, studies now confirm that the
incidence of HIV-1 non-B subtypes is increasing all over the world. A test's
ability to detect a broader range of these genetically diverse viruses will,
therefore, be crucial to HIV patient care on a global basis.
"We are very pleased to receive FDA clearance for this newest generation of
PCR HIV-1 viral load testing," said Heino von Prondzynski, Head of Roche
Diagnostics and member of Roche's Corporate Executive Committee. "The Cobas
Amplicor HIV-1 Monitor Test (version 1.5) will allow laboratories to deliver
quality HIV viral load results in a shorter time, thanks to cutting edge
automation."
According to the World Health Organization, more than 42 million people
worldwide were living with HIV at the end of 2002, an infection rate that is
expected to increase. The demand for antiretroviral therapy and consequently,
viral load testing, is expected to rise accordingly. Roche Diagnostics
provides both manual and automated HIV-1 RNA reagent kits and testing systems
to laboratories throughout the world.
Roche in HIV
Roche is at the forefront of efforts to combat HIV infection and AIDS,
committed since 1986 to groundbreaking research and development of innovative
new drugs and diagnostic technology. Saquinavir was the first Protease
Inhibitor (PI) and was first introduced by Roche in 1995 in the US. Fuzeon is
the first fusion inhibitor, representing the first new class of anti-HIV
treatments in seven years. Unlike all currently approved anti-HIV drugs,
Fuzeon blocks the virus from entering the human immune cell.
About Roche
Headquartered in Basel, Switzerland, Roche is an innovation driven global
healthcare leader focused on pharmaceuticals and diagnostics. Roche is
worldwide number one in diagnostics and oncology and has a leading position
in virology and transplantation. With products and services that address the
prevention, diagnosis and treatment of diseases, the company contributes
broadly to the enhancement of people's health and quality of life. Roche
employs some 62,000 people in more than 150 countries around the world. The
company has business alliances and R&D relationships with numerous partners,
including majority ownership interests in Genentech and Chugai, which are
both members of the Roche Group. Roche's Diagnostics Division, the world
leader in in-vitro diagnostics with a uniquely broad product portfolio,
supplies a wide array of innovative testing products and services to
researchers, physicians, patients, hospitals and laboratories worldwide. For
further information, please visit our websites www.roche.com.
Roche Molecular Systems, Inc., U.S.
Paula Evangelista
Director, Communications
Phone: 925-730-8374
Fax: 925-730-8378
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