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Last updated on April 16, 2014 at 8:57 EDT

Improved Testing for Hepatitis B Virus From Roche

December 8, 2008

PLEASANTON, Calif., Dec. 8 /PRNewswire/ — Roche Molecular Diagnostics
announced today that it has received CE Mark certification for its new
COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HBV Test v2.0, allowing it to be sold
for clinical use in the European Union. This highly sensitive test offers
Roche’s fully automated real-time PCR technology to achieve a broad dynamic
range for the quantitative detection of hepatitis B virus (HBV) DNA in patient
plasma and serum. According to the World Health Organization, approximately 2
billion people worldwide and about 350 million live with chronic HBV infection
and are at risk of developing end stage liver disease and liver cancer.(1)

“It is critical to monitor the levels of circulating hepatitis B virus as
an indicator as to when hepatitis B therapies should be started, and to
determine response to treatment,” said Teresa Wright, M.D., Chief Medical
Officer at Roche Molecular Diagnostics. “This test enables doctors to optimize
patient treatment with standardized viral load measurements and enables
laboratories to test efficiently with improved automation.”

Hepatitis B viral load testing enables clinicians to quantify the amount
of hepatitis B virus in a patient’s blood, select patients for treatment,
predict and assess individual responses to therapy and assess patients’
responses to therapy when they undergo treatment.

About the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HBV Test v2.0

The Roche COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HBV Test v2.0 can detect
genotypes A-H and pre-core mutants. It offers a broader dynamic range than
previous generation tests, from as low as 20 IU/mL and as high as 1.7E+08
IU/mL, enabling physicians to improve viral load monitoring. The assay
offers both serum and plasma specimen type and only uses 650 microliters
sample processing volume.

This test is designed for use on Roche’s automated platform that was CE
Mark certified in 2005. The platform combines the COBAS(R) AmpliPrep
Instrument for automated sample preparation and the COBAS(R) TaqMan(R)
Analyzer or the smaller COBAS(R) TaqMan(R) 48 Analyzer for automated real-time
PCR amplification and detection.

“Sample in/results out” testing eliminates manual intervention between
steps and configuration options allow for customizable solutions for
throughput needs. For a flexible throughput solution, the test offers up to 72
tests per kit in self sealing, ready-to-use reagent cassettes. Roche’s
proprietary AmpErase enzymes are also included in each test and are designed
to prevent cross-contamination of samples and labs.

About Hepatitis B

According to the World Health Organization, three quarters of the world’s
population live in areas where there are high levels of hepatitis B infection.
Even with a Hepatitis B vaccine, which has been available since 1982, about
600,000 people a year die from chronic active hepatitis, cirrhosis or primary
liver cancer.(1)

The Hepatitis B virus is spread through having unprotected sex, by sharing
needles, or from an infected mother to her baby during child birth. Symptoms
occur in about 70 percent of patients and include jaundice, fatigue, abdominal
pain, loss of appetite, nausea and vomiting.

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, and is a market
leader in virology. It is also active in other major therapeutic areas such as
autoimmune diseases, inflammatory and metabolic disorders and diseases of the
central nervous system. In 2007 sales by the Pharmaceuticals Division totaled
36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3
billion francs
. Roche has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and Chugai, and
invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group
employs about 80,000 people. Additional information is available on the
Internet at http://www.roche.com.

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

     For further information please contact:
     Jessica E. Brillant
     Molecular Diagnostics Communication
     925.730.8503

    (1) World Health Organization.  http://www.who.int

SOURCE Roche Molecular Diagnostics


Source: newswire