Roche's Test for Cytomegalovirus Is Approved in Europe

By Roche Molecular Systems, PRNE
Wednesday, March 30, 2011

Test measures viral load of potentially deadly virus for transplant patients

PLEASANTON, California, March 31, 2011 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its
Cytomegalovirus (CMV) test(1) is now commercially available in Europe. CMV
viral load testing helps physicians manage immunocompromised patients at risk
of CMV disease, including those who have undergone solid organ and stem cell
transplantation. This standardized and fully automated test monitors CMV
infections using an easy-to-operate system capable of delivering accurate and
reliable results to clinicians so that they can make critical treatment

"We are pleased to offer this innovative test to address a key medical
need for immunosuppressed patients," said Paul Brown, Ph.D., Head of Roche
Molecular Diagnostics. "With this test, Roche now enables rapid, standardized
CMV testing while improving workflow for laboratories."

About this test

The test is traceable to the first WHO International Standard for Human
Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162) and
reliably monitors cytomegalovirus (CMV) infections and the effect of
antiviral therapy on viral activity.

About COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System

This test is designed for use on Roche's fully automated COBAS(R)
AmpliPrep/COBAS(R) TaqMan(R) System. 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. The COBAS(R)
AmpliPrep/COBAS(R) TaqMan(R) System has parallel processing with other key
molecular diagnostics assays targeting medically relevant diseases (Hepatitis
B virus, Hepatitis C virus, and Human Immunodeficiency Virus). Roche's
proprietary AmpErase enzymes are also included in each test and are designed
to prevent cross-contamination of samples and labs.

About Cytomegalovirus

CMV is the most common and single most important viral infection in solid
organ transplant (SOT) recipients. CMV can be transmitted through the donor
organ resulting in CMV infection and leading to the development of CMV
disease. Approximately 20-60% of all transplant recipients develop
symptomatic CMV infection.(2) CMV infection usually develops during the first
few months after transplantation. CMV disease is defined by evidence of CMV
infection with attributable symptoms similar to infectious mononucleosis or
glandular fever, prolonged fever, sore throat, and a mild hepatitis. Once
infected, the virus remains latent in the body for the rest of the person's

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 2010, Roche had over 80'000 employees worldwide and invested
over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 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 protected by law.

(1) COBAS(R) AmpliPrep/COBAS(R) TaqMan(R). The COBAS(R) AmpliPrep/
COBAS(R) TaqMan(R) CMV Test is not approved or available for use in the US
and is currently in development

(2) Emovon OE, Baillie GM, Rajagopalan PR, Chavin KD. Infections after
kidney transplantation. CME Coverage, based on Renal Week 2002: American
Society of Nephrology 35th Annual Meeting. Medscape Transplantation. 2002.

Roche Molecular Systems Pleasanton Phone: +1-888-545-2443


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