FDA Accepts for Review New Roche Diagnostics Blood Screening Test



    
    Automated test is designed to detect broader range of HIV and hepatitis in
    a single multiplex assay.
    

    PLEASANTON, Calif., March 7 /CNW/ -- Roche Diagnostics announced today
that the United States (U.S.) Food & Drug Administration has accepted for
review its application for a new test designed to detect a broad range of
human immunodeficiency virus (HIV) and viral hepatitis infections in donated
blood and plasma. The test, called the cobas TaqScreen MPX Test, uses real-
time PCR to detect HIV type 1 (Groups M & O), HIV type 2, hepatitis C virus
(HCV), and hepatitis B virus (HBV) in a single multiplex assay. The test is
designed for use on Roche's newly automated, modular cobas s 201 platform.
Nucleic acid amplification technologies such as PCR allow earlier and more
specific detection of active infections in donated blood than earlier
generation serology tests, helping to ensure a safer blood supply and
retention of donors who would otherwise be deferred.
    "We are pleased to have reached this important milestone in bringing
multiplex testing and full automation to the U.S. blood-screening market,"
said Daniel O'Day, head of Roche Molecular Diagnostics, a business area of
Roche Diagnostics that developed the test.  "We believe this automated test,
with detection of HIV-1 Group O and HIV-2, may help blood banks and
laboratories improve blood safety, workflow efficiency, and donor retention.
In addition, the system's modular design and optional built in back-ups are
designed to minimize downtime in this highly time-sensitive industry."
    The U.S. Centers for Disease Control estimates that there are more than a
million people in the U.S. living with HIV/AIDS, with an additional 40,000
people being infected each year. It is estimated that 300,000 infected persons
are unaware of their HIV status. More than 4 million people in the U.S. have
been infected with HCV, 3.2 million of whom are chronically infected. HCV is
the leading cause of liver cancer in the U.S. and is the leading diagnosis in
patients undergoing liver transplantation. More than 1,200,000 people are
chronically infected with HBV and about 5,000 people die of complications of
HBV every year. Many individuals with HBV and HCV show no symptoms of disease
and do not know that they are infected. These individuals may attempt to
donate blood. The cobas TaqScreen MPX assay is designed to identify infected
blood from these potential donors, before they inadvertently transmit
infection to others.

    
    About HIV-1 and HIV-2(i)
    
    Human immunodeficiency virus type 1 (HIV-1) was discovered in 1984, 3
years after the first reports of a disease that was to become known as AIDS.
In 1986, a second type of HIV - less common in the U.S. - was discovered,
called HIV-2. The most common form of HIV-1 is called HIV-1 Group M. In 1994,
the first report confirming the identification of a different form of HIV-1,
called HIV-1 Group O, was published, with the first case in the U.S. being
reported in 1996.

    
    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 a world leader in
diagnostics, the leading supplier of drugs for cancer and transplantation and
a market leader in virology. In 2006 sales by the Pharmaceuticals Division
totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales
of 8.7 billion Swiss francs. Roche employs approximately 75,000 people in 150
countries and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and Chugai.
Roche's Diagnostics Division offers a uniquely broad product portfolio and
supplies a wide array of innovative testing products and services to
researchers, physicians, patients, hospitals and laboratories world-wide. For
further information about Roche, please visit our website www.roche.com.
    For more information about Roche Molecular Diagnostics, please visit
http://molecular.roche.com .
    Tests under review by the FDA are not available for use in the United
States until the agency has approved the application for each test.

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

    (i) Information in this section comes from the United States Centers for
Disease Control website at http://www.cdc.gov and from the United States Food
and Drug Administration web site at
www.fda.gove/bbs.topics/ANSWERS/ANS00747.html

    Contact:  Rick Roose of Roche Molecular Diagnostics, +1-925-730-8415, or
rick.roose@roche.com.





For further information:

For further information: Rick Roose of Roche Molecular Diagnostics, 
+1-925-730-8415, or rick.roose@roche.com Web Site: http://www.roche.com/

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