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Roche Diagnostics Begins Installation of West Nile Virus Blood
Screening Systems
at North American Blood Centers in Preparation for Clinical Trials
PLEASANTON, California (April 22, 2003) - Roche Diagnostics announced
today that it has begun installation of its West Nile virus blood
screening systems at leading North American blood centers, in preparation
for clinical trials scheduled to begin on or before July 1. The
test, which uses Roche's industry-leading polymerase chain reaction
technology to amplify the genetic material of West Nile virus to
detectable levels, represents an important step in helping blood
banks ensure the safety of blood and blood products used in transfusions
and other medical procedures.
In the United States, systems were installed at two America's Blood
Centers testing sites: the Gulf Coast Regional Blood Center in Houston,
Texas, and the Central Florida Blood Bank in Orlando, Florida, and
also at the South Bend Medical Foundation testing site in Indiana.
In Canada, systems were installed at Canadian Blood Services and
Hema-Quebec testing sites. Roche will continue installations of
its West Nile virus systems at additional testing sites in the United
States and Canada throughout May and June.
"We are very pleased with the exceptionally rapid progress
Roche has made developing this nucleic-acid test for West Nile Virus,"
said Celso Bianco, Executive Vice President of America's Blood Centers,
an association of locally controlled blood centers that provides
almost half of the US blood supply. "Roche's use of its PCR-based
technology platform to automate the extraction, amplification, and
detection steps have been as important to us as the company's development
of the assay in time for the 2003 mosquito season. Roche's automated
platform brings blood donor screening at our high-volume blood centers
to a new level of sophistication, and helps us deliver our life
saving blood products to hospitals and patients in a timely fashion.
Roche's test represents the way of the future."
West Nile virus was first observed in the United States in 1999.
In 2002, according to the Centers for Disease Control (CDC), an
epidemic of more than 4,100 West Nile virus infections in the United
States resulted in 284 deaths. Although mosquitoes remain the most
common means of transmission of West Nile virus, the US Food and
Drug Administration (FDA) and 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 2003, the US Food
and Drug Administration and Centers for Disease Control last September
called on industry to have a blood screening test for West Nile
virus ready for the 2003 mosquito season. Canada experienced its
first fatal case of West Nile virus in 2002, prompting Health Canada
to include screening of donated blood as part of its national strategy
to reduce the risk of West Nile virus infection.
"We designed this system to help our customers to meet the
requests of their regulatory agencies on or ahead of schedule,"
said James Gallarda, Ph.D., Director of Blood Screening at Roche
Molecular Diagnostics in Pleasanton, California, the business area
of Roche Diagnostics responsible for development of the test. "We
remain committed to providing blood banks with fully automated systems
that will allow them to keep up with the increasing demands of ensuring
the safety of their blood supplies."
About West Nile Virus
Although present in North America, West Nile virus and other members
of the Japanese Encephalitis virus group are more commonly found
in Africa, West Asia, the Middle East, Central America, South America,
and Australia.
For most individuals, infection with the virus causes no symptoms
or mild flu-like symptoms that resolve in several days without harm.
But for others, especially people over the age of 60 or those with
compromised immune systems, these viruses can cause life-threatening
medical conditions, including encephalitis (inflammation of the
brain), meningitis (inflammation of the membrane around the brain
and the spinal cord), or meningoencephalitis (inflammation of the
brain and the membrane surrounding it).
About Roche's Patented PCR Technology
Roche's patented polymerase chain reaction (PCR) technology, the
world's leading nucleic acid amplification technology, allows minute
amounts 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 DNA 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.
The majority of testing to understand the spread of West Nile virus
in the United States has relied on PCR technology. Several national
and state-level public health agencies use 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 in these and a wide variety of other
areas.
About Roche Diagnostics and Blood Screening
Roche is the leading diagnostic provider for the international blood
bank market. Roche's PCR-based AmpliNAT™ system, which includes
a triplex assay for simultaneously detecting HIV, Hepatitis B, and
Hepatitis C infections in donated blood, has been used exclusively
by the Japanese Red Cross since 1999 to screen the country's entire
blood supply. Roche's PCR-based AmpliScreen® tests for detecting
HIV and Hepatitis C in donated blood have been approved for use
in the US and several other countries. Roche's AmpliScreen test
for Hepatitis B is in clinical trials in the United States and is
commercially available in several other countries. Roche's blood
screening products are also used in countries where product registration
is not required.
About Roche
Headquartered in Basel, Switzerland, Roche is an innovation driven
global healthcare leader focused on pharmaceuticals and diagnostics.
Worldwide, Roche is number one in diagnostics, oncology and transplantation
and has a leading position in virology. 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 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
and www.roche-diagnostics.com.
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