First Duplex Test for Parvovirus B19 and Hepatitis A Virus Increases Safety of Human Plasma and Plasma Products

By Roche, Gaea News Network
Sunday, October 3, 2010

cobas(R) TaqScreen DPX Test offers real-time discrimination in a single assay(1)

PLEASANTON, California, October 4, 2010 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the cobas(R)
TaqScreen DPX Test for use on the cobas s 201 system is now available with
the CE Mark. It is the first IVD test to offer complete coverage of all human
genotypes of parvovirus B19 (B19V) and hepatitis A virus (HAV) in one assay.
The test is a state-of-the-art, in-vitro nucleic acid amplification
technology (NAT) test which simultaneously quantifies B19V genotypes 1, 2 and
3 DNA and detects HAV genotypes I, II and III RNA in individual samples or
pooled plasma samples of human origin.

The cobas(R) TaqScreen DPX Test uses multi-dye, real-time polymerase
chain reaction (PCR) technology which allows for the simultaneous detection
and identification of individual viral targets without the use of
complementary discriminatory tests. The introduction of the cobas(R)
TaqScreen DPX Test makes the cobas s 201 system the first commercially
available NAT system for screening blood and plasma for six viruses.

"Roche is committed to providing the broadest coverage and most efficient
screening tests to ensure the highest safety of blood and plasma products,"
said Paul Brown, Ph.D., President and CEO of Roche Molecular Diagnostics.
"This new test is one more step toward that goal and complements our current
cobas(R) TaqScreen tests for the detection of HIV, HCV, HBV and WNV."

The cobas(R) TaqScreen DPX Test can help manage the B19V burden in plasma
pools and identify HAV-contaminated units. It allows plasma manufacturers to
increase processing efficiency and may reduce the number of units that are
discarded. The highly precise, quantitative values obtained for B19V DNA and
the test's high sensitivity for HAV RNA meet current regulatory requirements
for plasma intended for further manufacture.

Human plasma is fractionated into its components, such as immunoglobulins
, albumin, and clotting factors, which have many therapeutic uses. These
include treatment of chronic and hereditary diseases and disorders such as
hemophilia and primary immunodeficiency diseases. Plasma is also used to
treat patients who have suffered severe burns or trauma, and during major

The presence of B19V DNA in plasma pools as well as plasma products has
been reported to be associated with the transmission of B19V by
administration of plasma products, especially coagulation factors. There have
also been reports on the transmission of HAV through blood and plasma
products. Both B19V and HAV are not easily inactivated by traditional methods
and so detection by NAT is an important step in ensuring the safety of blood
and plasma products.

About Roche Blood Screening

Roche is a leader in the global NAT blood screening and plasma market,
which is estimated at almost 900 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 225
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 personalised
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

(1) Not available for sale in the US

    For further information please contact:

    Marianne van Zeeland
    Roche Molecular Diagnostics
    +1-925-549-1232 (Mobile)

Marianne van Zeeland of Roche Molecular Diagnostics Communications, +1-925-549-1232, marianne.van_zeeland at

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