Roche Diagnostics Submits Hepatitis C Viral Load Monitoring Test to FDA

Test designed to give doctors highly accurate results and to improve workflow efficiency for labs

Roche Diagnostics announced today that it has submitted its automated test for Hepatitis C viral load monitoring to the U.S. Food & Drug Administration (FDA) for review. The FDA will review the application to determine whether the test can be marketed for diagnostic use in the United States. The test, called the COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, is designed to provide highly accurate information about the quantity of Hepatitis C virus in a patient’s blood, from very high to very low levels. This type of diagnostic, called “viral load testing,” is a key measure of how well a patient infected with Hepatitis C is responding to drug therapy.

“This is an important milestone in the development of our automated virology portfolio for the US market.” said Daniel O’Day, head of Roche Molecular Diagnostics, the business area of Roche Diagnostics that developed the test. “As the global leader in molecular diagnostics, our goal is to continue to increase system integration and automation, enabling labs to deliver reliable healthcare information with greater ease and efficiency.”

Hepatitis C is an often silent (asymptomatic) blood-borne infection of the liver, yet one that can cause serious chronic disease, liver failure, in some cases, death. According to the U.S. Centers for Disease Control, an estimated 4.1 million Americans have been infected with Hepatitis C virus, 3.2 million of whom are chronically infected. Combination therapy with pegylated interferon and ribavirin drugs (currently the treatment of choice) can get rid of the virus in up to 5 out of 10 persons infected with genotype 1 of the Hepatitis C virus, and up to 8 out of 10 persons infected with genotypes 2 and 3.

About the Roche Molecular Diagnostics Virology Portfolio
Roche Molecular Diagnostics (RMD), the global leader in molecular diagnostics, develops a broad range of tests based on the company’s Nobel Prize-winning PCR technology. RMD tests for HIV and Hepatitis B & C provide actionable health information designed to help improve disease management through diagnosis of active infections, quantification of the amount of virus in the blood (viral load monitoring), and identification of drug resistance and disease recurrence.

RMD’s newest generation of automated real-time PCR tests – the COBAS® AmpliPrep/COBAS® TaqMan® HIV-1, Hepatitis C, and Hepatitis B tests – have been available for diagnostic use in the European Union since 2005. The COBAS® AmpliPrep/Cobas® TaqMan® HIV-1 and Hepatitis C tests are currently under review by the FDA. The tests are designed for improved workflow efficiency and test results integrity, including configuration options that enable fully automated “sample in, results out” processing.

The FDA is also currently reviewing the Roche Diagnostics COBAS® TaqMan® HBV Test, which is designed for use with High Pure sample preparation reagents and the COBAS® TaqMan® 48 analyzer for automated amplification and quantitation of Hepatitis B virus in human blood.

Not all tests are available in all countries. Tests under review by the FDA are not available for diagnostic use in the United States until the agency has approved the pre-market notification application for each test.

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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, 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 medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totaled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 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, please visit our website www.roche.com

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For further information please contact:
Melinda Baker
Molecular Diagnostics Communications
Phone: +1 925-730-8379