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IMPROVED HIV VIRAL LOAD TEST APPROVED BY THE FDA
HIGHLY SENSITIVE TEST, ROCHE AMPLICOR HIV-1 MONITOR®,
NOW PROVIDES BETTER COVERAGE OF HIV-1 VIRAL SUBTYPES
INDIANAPOLIS, IN, July 31, 2002 - Today Roche Diagnostics announced
that on July 26, 2002, it received marketing approval from the U.S.
Food and Drug Administration (FDA) for the Roche AMPLICOR HIV-1
MONITOR® Test, version 1.5.
This test is a highly sensitive laboratory test to measure levels
of HIV circulating in an infected person's blood ("viral load").
The test can measure HIV-1 RNA over the range of 50-750,000 copies
per milliliter and detect Group M subtypes A-G of the virus, and
is the only FDA-approved test to measure HIV-1 RNA down to 50 copies
per milliliter. With the prevalence of non-B subtypes increasing
worldwide, the ability of a test to detect and quantify these diverse
subtypes is crucial in HIV patient care.
"This is a significant achievement for HIV-1 treatment. Research
has shown us the importance of measuring viral load levels to as
low a level as possible," commented William Valenti, M.D.,
an AIDS-treating physician and researcher, Founding Medical Director
of Community Health Network, and Associate Professor of Medicine
at Rochester University School of Medicine, Rochester, NY. "Having
a test that will also detect a wide range of HIV subtypes is essential
in improving patient care and outcomes, and in our overall understanding
of how well patients are doing. The revolutionary technology of
AMPLICOR, a critical surrogate marker, has changed the way we look
at the progression of the disease in the patient and the patient's
response to treatment. It has been used in the development of most
of the current FDA-approved antiretroviral therapies as well as
those still in development."
Measuring viral load level is an important part of assessing a
patient's disease prognosis and response to drug therapy, enabling
the physician and patient to make informed treatment choices and
to help achieve an optimal positive response to therapy. Studies
indicate that lowering plasma HIV RNA below 50 copies per milliliter
is a strong indicator of viral suppression.1
"I've been on several different regimens of HIV medications
over the past few years," explained Michael Lee, a patient
of Dr. Valenti who has lived with HIV infection for more than 10
years. "Not long ago, I interrupted my therapy because I was
feeling so good. When I stopped my treatment, this test detected
an increase in my viral load level, giving me the information I
needed to make the decision to resume my treatment regimen."
"With a specificity of 100% and a sensitivity down to 50 copies
per milliliter, clinicians and patients can be confident of being
able to detect a broad range of subtypes, and thus gain an accurate
picture of their disease," explained Tadd Lazarus, M.D., Director
of Medical Affairs for Roche Diagnostics, an HIV primary care internist
at St. Vincent's Hospital in New York City and Assistant Professor
of Clinical Medicine at New York Medical College. AMPLICOR is the
test of choice for HIV therapy clinical trials, having been used
thus far in 15 of the 17 pivotal trials of pharmaceuticals currently
FDA-approved for antiretroviral therapy.
"Providing physicians, clinical laboratories and patients
with the most advanced HIV diagnostic testing remains paramount
to our mission of being a true innovative health information provider,"
stated Heino von Prondzynski, Head of the Roche Diagnostics Division.
"It's not by chance that we are the worldwide market leader
in the HIV testing arena," he continued. " Only by responding
to the changing face of the AIDS epidemic with state-of-the-art
diagnostics technology derived from intensive research efforts are
we able to accomplish this, and, in doing so, we hope we're continuing
to make a difference in AIDS patients' lives."
The Roche AMPLICOR HIV-1 MONITOR Test, version 1.5, is based on
Nobel Prize-winning polymerase chain reaction (PCR) technology.
PCR allows the amplification and identification of specific DNA
or RNA sequences from a patient's blood sample. Because PCR is able
to detect the presence of virus in an individual's genetic material,
it has emerged as the "gold standard" in managing infectious
diseases such as HIV.
Subtype Prevalence
Researchers have identified several subtypes of the HIV-1 virus.
These subtypes are considered to be mutations of the virus and prevalence
is varied by geography across the continents and various regions.
Subtype B is the most prevalent in the U.S., Europe, South America,
and Australia, though there has been an increasing prevalence of
other subtypes in some of these areas, including the U.S. The Indian
subcontinent and parts of Asia report a wider variety of subtypes,
while Africa has the most diverse prevalence. Research also suggests
that certain subtypes may be associated with specific modes of HIV
transmission.
About Roche Diagnostics
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-oriented health care groups in the fields of pharmaceuticals,
diagnostics, and vitamins. Roche's products and services address
prevention, diagnosis, and treatment of diseases, thus enhancing
well-being and quality of life. Roche's Diagnostics Division, the
world and U.S. 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. Roche Diagnostics Corporation, based in
Indianapolis, is the North American headquarters for the diagnostics
business of the company. Roche Diagnostics' website is located at
www.roche-diagnostics.com.
1 Powderly WG, Saag MS, et al. Predictors of optimal virological
response to potent antiretroviral therapy. AIDS. 1999; 13: 1873-1880
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