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Roche's TaqScreen™ West Nile Virus Blood Screening Test
Can Also Detect Other Members of the Potentially Deadly Japanese
Encephalitis Virus Group
PCR-based assay scheduled to begin clinical trials in the
US and Canada on or before July 1
PLEASANTON, California - Roche Diagnostics, the world's leading
provider of nucleic acid-based blood screening products, announced
today that its new assay for detecting West Nile virus in donated
blood can simultaneously detect other members of the Japanese Encephalitis
virus group, of which West Nile virus is a member. Roche's studies
have shown that its TaqScreen™ West Nile Virus Test can detect
West Nile virus (including the Kunjin and New York strains), St.
Louis Encephalitis virus, Japanese Encephalitis virus, and Murray
Valley Encephalitis virus. Roche's test represents an important
milestone in local and international efforts to prevent the spread
of these potentially deadly viruses through the transfusion of blood
and blood products.
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. Canada issued similar guidance to
blood banks in 2002.
To date, Roche is the only company to announce a nucleic acid test
capable of detecting West Nile virus and other members of the Japanese
Encephalitis virus group in donated blood. In addition, Roche's
West Nile virus test will be the first and only fully automated
nucleic acid testing system to be introduced under an Investigational
New Drug Application into the blood screening market. Full automation
is an important feature for blood banks trying to manage the costs
and workflow associated with the new testing requirements.
"Roche responded in record time to the FDA's call to action,"
said Richard Thayer, Vice President of Blood Screening at Roche
Molecular Diagnostics, the business area of Roche responsible
for developing the test. "At the same time, we were able to
introduce next-generation features that automate the extraction,
amplification, and detection steps. We feel strongly," continued
Thayer, "that the full automation of our system and the ability
of our test to detect other Japanese Encephalitis virus group members
offers blood banks an essential advantage in a world where the spread
of infectious agents can be accelerated by travel. As the world
leader in the international molecular blood screening market, we
remain committed to driving innovation and providing our customers
with the most comprehensive and reliable tools for ensuring the
safety of their blood supplies."
To further improve the blood screening process, Roche introduced
"generic extraction" as a feature of its TaqScreen West
Nile virus test. Generic extraction isolates the genetic material
(nucleic acids called DNA or RNA) of any infectious agent, viral
or bacterial, present in a sample of donated blood before a test
for a specific infectious agent, such as West Nile virus, is performed.
Capturing this broader range of genetic material in the extraction
process makes it possible to "multiplex" tests, that is,
to perform several screening tests simultaneously on the same sample
of blood.
"Three features distinguish Roche's West Nile Virus test,"
explained James Gallarda, Director of Blood Screening Development
at Roche Molecular Diagnostics. "First, its broader coverage,
made possible by the detailed genetic research our scientists conducted
up front to understand the Japanese Encephalitis group of viruses.
Second, total automation, an important feature for blood banks working
hard to ensure the safest possible blood supplies. And third,"
continued Gallarda, "generic extraction, which adds further
value by allowing us to respond more quickly should our customers
need to screen for other emerging pathogens."
Clinical trials of Roche's TaqScreen West Nile Virus test are scheduled
to begin in the United States and Canada on or before July 1. The
trials are designed primarily to demonstrate the test's clinical
performance for detecting West Nile virus. Roche also expects the
clinical trials and other non-clinical studies to provide additional
data about the test's performance in detecting other members of
the Japanese Encephalitis virus group.
About West Nile Virus
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. 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 individuals, infection with these viruses 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, infection with 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, is an essential
component of Roche's blood screening assays and other diagnostic
products. PCR 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 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 diagnostic products
for the international blood bank market. Roche's PCR-based AmpliScreen®
tests, which include assays for detecting HIV 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 company's AmpliScreen assay for Hepatitis B
is currently in clinical trials in the United States. Roche'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, 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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