Blood Screening Test That Offers Immediate Viral Discrimination for Three Major Viruses Receives CE Mark

By Roche, PRNE
Sunday, May 22, 2011

PLEASANTON, California, May 23, 2011 -

- cobas(R) TaqScreen MPX Test, v2.0(1) provides real-time results for

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the cobas(R)
TaqScreen MPX Test, version 2.0 for use on the cobas s 201 system is now
commercially available in Europe.

This latest version of the widely used cobas(R) TaqScreen MPX Test
provides increased sensitivity and is the only commercially available test
that provides simultaneous viral target resolution on an automated system,
removing the need for further time-consuming testing of positive units.

The test is a qualitative in vitro test for the direct detection of Human
Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human
Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and
Hepatitis B Virus (HBV) DNA in human plasma. This test is intended for use to
screen samples of donations of human whole blood and blood components
including source plasma.

"Roche is the global market leader in testing sites and donations
tested," said Paul Brown, Head of Roche Molecular Diagnostics, the business
area of Roche that developed the test. "By continually developing innovative
products we are striving for the highest level of blood safety for patients
and efficiency for blood centers. This test takes us one step closer to those

As a result of Roche's process to globally monitor viral genome databases
to track changes that may occur in viral sequences, the assay has been
reformulated to include as many recent viral sequences as possible increasing
the inclusivity range of viral targets.

The cobas(R) TaqScreen MPX Test, v2.0 also offers increased efficiencies
for blood centers by removing the need for viral discriminatory testing,
thereby reducing the sample volume required and the turnaround time for donor
testing. By utilizing real-time, multi-dye PCR technology, results are
simultaneously detected and discriminated for HIV, HCV and HBV for an
individual specimen, eliminating the need for additional time-consuming
discriminatory tests that other commercially available tests require.

The test runs on the fully automated cobas s 201 system, which is
designed to increase processing efficiency in a unique modular design with
ready-to-use reagents. The multi-dye technology allows signal detection in
four separate channels, facilitating simultaneous monitoring of three viral
targets (HIV, HCV and HBV) plus a full-process internal control. In addition
to HIV, HCV and HBV, the menu of the cobas s 201 system includes tests for
West Nile virus, parvovirus B19 (B19V) and hepatitis A virus (HAV).(2) All
Roche blood screening tests are based on Nucleic Acid Amplification
Technology (NAT) which offers earlier detection of viruses than traditional
serology testing. The cobas s 201 system offers the most comprehensive NAT
test menu available on a single automated platform.

(1) This product is not approved or available for use in the US.

(2) The duplex test for B19V and HAV has been filed with the FDA under a
Drug Master File. It is available to US laboratories who meet specific FDA

About Roche Blood and Plasma Screening

Roche is a leader in the global blood and plasma NAT screening market,
which is estimated at almost 800 million CHF. Nucleic acid-based tests enable
earlier detection of active viral infections than conventional antibody or
antigen assays. Roche's real-time PCR-based nucleic acid assays have been
used since 1998 to screen blood and plasma products. Currently, more than 250
blood banks worldwide use Roche's automated cobas s 201 system.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in pharmaceuticals and
diagnostics. Roche is the world's largest biotech company with truly
differentiated medicines in oncology, virology, inflammation, metabolism and
CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based
cancer diagnostics and a pioneer in diabetes management. Roche's personalized
healthcare strategy aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of
patients. In 2009, Roche had over 80,000 employees worldwide and invested
almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion
Swiss francs
. Genentech, United States, is a wholly owned member of the Roche
Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more

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

    For further information please contact:
    Marianne van Zeeland
    Roche Molecular Diagnostics Communications
    +1-925-549-1232 (Mobile)


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