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Roche Diagnostics Receives FDA Authorization to Begin Clinical
Trials for TaqScreen™ West Nile Virus Test
Roche is first company to receive authorization to begin prospective
testing at US Blood Centers.
PLEASANTON, California - Roche Diagnostics, the world's leading
provider of nucleic acid-based blood screening products, announced
today that it has received authorization from the United States
Food & Drug Administration (FDA) to begin clinical trials of
the TaqScreen™ West Nile Virus Test, the first PCR-based nucleic
acid system to fully automate the specimen processing, amplification,
and detection steps in blood screening. Roche created the test in
record time to address concerns expressed by the FDA and Centers
for Disease Control and Prevention (CDC) last September about the
potential for an increase in transfusion-related West Nile Virus
infections during the 2003 mosquito season.
To date, Roche is the only company to receive FDA authorization
to begin screening newly donated blood (versus archived samples)
at US blood centers. As part of the clinical trial, samples of all
blood donated at participating blood centers will be tested for
West Nile virus. As part of its non-clinical studies, Roche will
also include testing of archived blood samples.
The company's clinical trials are scheduled to begin in the United
States and Canada (where Roche has filed a separate clinical trial
application) on or before July 1. Eleven blood testing laboratories
will screen samples from a network of nearly 100 local donation
centers across the United States, including Alaska and Hawaii.
"We appreciate the confidence that the FDA has expressed in
the platform and assay data submitted with our Investigational New
Drug application," said Richard Thayer, Vice President of Blood
Screening at Roche Molecular Diagnostics, the business area of Roche
Diagnostics responsible for developing the test. "Results from
our non-clinical studies as well as preliminary feedback from customers
give us every confidence that our test will perform well in screening
newly donated blood."
Roche's non-clinical studies have also shown that, in addition
to West Nile virus (Kunjin and New York strains), its test can detect
other potentially deadly members of the Japanese Encephalitis virus
group, including St. Louis Encephalitis virus, Japanese Encephalitis
virus, and Murray Valley Encephalitis virus. A subset of the blood
donations that test positive in the company's trials for West Nile
virus will be sent for further laboratory testing to determine the
specific member of the Japanese Encephalitis group virus infecting
the blood.
"We fully expect that our TaqScreen West Nile Virus Test will
be a valuable tool for North American blood banks working hard to
ensure the safety of their blood supplies," said Heiner Dreismann,
Ph.D., Head of Roche Molecular Diagnostics. "This test is further
evidence of our ongoing commitment to providing fully automated,
next-generation products to the international blood screening community."
Background on the West Nile Virus
West Nile virus was first observed in the United States in 1999.
In 2002, an epidemic of more than 4,100 West Nile virus infections
in the United States resulted in 277 deaths. In previous years,
before nucleic acid-based blood screening was available, the US
also experienced periodic epidemics of St. Louis Encephalitis virus,
primarily in the Gulf Coast and Mississippi Valley regions of the
country.
For most people, infection with West Nile virus causes no symptoms,
or only mild flu-like symptoms (called West Nile fever). In a small
percentage of those infected, however, especially the elderly or
those with compromised immune systems, infection can progress to
serious, life threatening illnesses, including swelling of the brain
(encephalitis), the brain and the membrane surrounding it (meningoencephalitis),
or the membrane around the brain and spinal cord (meningitis).
Although mosquitoes remain the most common means of transmission
of these viruses, the United States Food and Drug Administration
(FDA) and Centers for Disease Control and Prevention (CDC) last
year indicated that a small number of West Nile virus cases had
likely spread through blood transfusions and tissue donations. Because
incidence of infection with West Nile virus is expected to increase
in North America in 2003, the FDA and CDC last September called
on industry to have a blood screening test for West Nile virus ready
for the 2003 mosquito season. In 2002, after outbreaks of West Nile
Virus in Canada, Canadian health authorities issued a request to
its blood banks to begin screening in 2003.
About Roche's Patented PCR Technology & West Nile Virus
Roche's patented polymerase chain reaction (PCR) technology, the
world's leading nucleic acid amplification technology, is an essential
component of Roche's blood screening assays and other diagnostic
products. PCR allows minute amounts of selected unique regions of
genetic material to be amplified into billions of copies (that is,
to detectable levels) in only a few hours. In addition to its applications
in nucleic acid fingerprinting and the diagnosis and monitoring
of disease, PCR enables detection of infectious agents in donated
blood earlier in the infection cycle, often before symptoms appear.
Standard immunoassay testing, in contrast, detects evidence of a
body's immune response (antibodies) later in the infection cycle,
leaving an increased period of time when infections can be missed.
To date, the majority of testing conducted to understand the spread
of West Nile virus in the United States has relied on Roche's PCR
technology. Several national and state-level public health agencies
have used PCR-based tools to better understand the epidemiology
of West Nile virus in humans and animals. Many healthcare providers
and veterinary technicians rely on PCR-based tests for diagnosing
the disease.
Through its global licensing and scientific collaboration programs,
Roche has developed and encouraged the utility of PCR technology
for a wide variety of clinical and research applications.
About Roche Diagnostics and Blood Screening
Roche is the leading provider of nucleic acid-based testing products
for the international blood bank market. Roche's PCR-based COBAS
AmpliScreen™ tests, which include assays for detecting HIV-1
and Hepatitis C in donated blood, have been approved for use in
the US and abroad, and are also used in other countries where product
registration is not required. The COBAS AmpliScreen assay for Hepatitis
B is currently in clinical trials in the United States and is also
used in other countries where product registration is not required.
The company's AmpliNAT™ system has been used exclusively by
the Japanese Red Cross since 1999 to screen Japan's entire blood
supply. Roche's AmpliNAT system is the first commercially available
blood screening system that can identify, in a single triplex reaction,
whether or not a blood sample is infected with HIV-1, Hepatitis
B, or Hepatitis C.
About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's
leading innovation-driven healthcare groups. Its core businesses
are pharmaceuticals and diagnostics. Roche is number one in the
global diagnostics market, the leading supplier of pharmaceuticals
for cancer and a leader in virology and transplantation. As a supplier
of products and services for the prevention, diagnosis and treatment
of disease, the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche employs roughly
62,000 people in 150 countries. The Group has alliances and research
and development agreements with numerous partners, including majority
ownership interests in Genentech and Chugai. 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 world-wide. For further information, please visit
our websites www.roche.com
and www.roche-diagnostics.com.
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