FDA Accepts for Review New Roche Diagnostics Blood Screening Test

FDA Accepts for Review New Roche Diagnostics Blood Screening Test

March 08, 2007

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

    PLEASANTON, Calif., March 8 /Xinhua-PRNewswire/ -- 

    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
http://www.fda.gove/bbs.topics/ANSWERS/ANS00747.html .

    For more information, please contact:  

     Rick Roose
     Roche Molecular Diagnostics
     Tel:   [phone]
     Email: [e-mail]