Health Canada Approves New Roche West Nile Virus Blood Screening Test



    Automated test helps ensure safety of blood supply by detecting virus
    earlier in infection cycle.

    LAVAL, QC, Dec. 19 /CNW Telbec/ - Roche Diagnostics announced that
Health Canada approved its medical device license application for the
company's screening test to detect West Nile Virus RNA in blood donations.
West Nile virus, which can cause serious health issues, is transmitted to
humans most often through mosquito bites, but can also less commonly be
transmitted by transfusion of infected blood or blood products. The test,
called the cobas TaqScreen West Nile Virus Test, enables detection of the
virus earlier in the infection cycle in donors who may show no symptoms of
disease. Blood screening centers across Canada have identified 107 donors
whose blood tested positive for West Nile Virus since screening for WNV began
in 2003.
    "We are extremely pleased with this latest news. It means that this high
quality screening test for West Nile Virus, that has been used effectively by
Canadian Blood Services and Héma-Québec since 2003 to optimize testing
efficiency and maximize blood safety, now also meets our rigorous Canadian
Regulatory requirements", said Christopher Parker, President and General
Manager of Roche Diagnostics Canada.
    The test is designed to run on the cobas s 201 system, Roche's flexible,
modular instrument platform which automates each step of the real-time PCR
blood screening process. The test uses Roche's highly sensitive polymerase
chain reaction technology (PCR), the world's leading nucleic acid
amplification technology, to detect the genetic material of the
West Nile virus directly in blood. The United States Centers for Disease
Control (CDC) has stated that screening donated blood for West Nile Virus by
nucleic acid amplification tests has markedly reduced the risk of transfusion
transmission.

    About West Nile Virus

    Most people infected with West Nile Virus never show signs of illness or
experience several days of flu-like symptoms, but others, especially those
with compromised immune systems, can suffer serious and in some cases life
threatening reactions. According to the US Centers for Disease Control, in
2002, transfusion-associated transmission (TAT) of West Nile virus (WNV)
infection acquired through blood transfusion marked the emergence of a new
threat to the U.S. blood supply. Although mosquito-borne transmission remains
the predominant mode of WNV transmission, identification of TAT underscored
the need for WNV screening of donated blood. In June 2003, blood-collection
agencies in North America implemented investigational WNV nucleic
acid--amplification tests (NATs) to screen all blood donations and identify
potentially infectious donations for quarantine and retrieval.

    About Roche Diagnostics Blood Screening

    Roche Diagnostics is the leading provider of PCR-based nucleic acid tests
for the international blood bank market. Nucleic acid-based tests enable more
highly sensitive detection than conventional antibody or antigen assays. Roche
assays have been used by the Japanese Red Cross since 1999 to screen Japan's
entire blood supply. In 2006, Roche launched the automated cobas s 201 system
and the 5-parameter multiplex cobas TaqScreen MPX Test in Europe for the most
comprehensive single-assay detection of HIV-1 groups M & O, HIV-2, and
Hepatitis B and C in donated blood and plasma. The West Nile Virus test is the
first test available on the automated cobas s 201 system in North America,
where the multiplex HIV, HCV, and HBV test is currently under Health Canada
and FDA review.

    About Roche and the Roche Diagnostics Division

    Headquartered in Basel, Switzerland, Roche is one of the world's leading
research-focused healthcare groups in the fields of pharmaceuticals and
diagnostics. As the world's biggest biotech company and an innovator of
products and services for the early detection, prevention, diagnosis and
treatment of diseases, the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche is the world leader in
in-vitro diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as autoimmune
diseases, inflammation, metabolic disorders and diseases of the central
nervous system. In 2006 sales by the Pharmaceuticals Division totalled
33.3 billion Swiss francs, and the Diagnostics Division posted sales of
8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances
with numerous partners, including majority ownership interests in Genentech
and Chugai, and invests approximately 7 billion Swiss francs a year in R&D.
Worldwide, the Group employs about 75,000 people. Additional information is
available on the Internet at www.roche.com.


    All trademarks used or mentioned in this release are legally protected by
    law.




For further information:

For further information: Michèle Beaubien, Communications, (450)
686-5500, michele.beaubien@roche.com


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