FDA Approves PCR Test
Roche's Qualitative AMPLICOR(R) HCV Tests Could Bring More Accurate Detection of Liver Disease to The Clinical Setting

INDIANAPOLIS, July 9 /PRNewswire
Roche Diagnostics Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for two hepatitis C tests designed to directly detect the presence of the hepatitis C virus (HCV) in patients who have evidence of liver disease and antibody evidence of HCV and who are suspected to be actively infected with HCV. The AMPLICOR(R) HCV Test, version 2.0, and the COBAS AMPLICOR(TM) HCV Test, version 2.0 are the first qualitative RNA tests to be approved for marketing by the FDA.

"As the prevalence of this potentially life-threatening disease grows, the demand for screening and diagnosis is also on the rise," said Michael Fried, Director of Clinical Hepatology, University of North Carolina at Chapel Hill. "The introduction of the AMPLICOR HCV Tests to the laboratory setting will help meet the growing demand for reliable, standardized hepatitis C testing and diagnosis -- and when appropriate, to treatment."

The AMPLICOR HCV Tests detect the presence of HCV RNA in serum and plasma; a positive result indicates current infection. The tests are the first - and only - FDA approved qualitative nucleic acid tests available through hospitals and licensed laboratories.

The AMPLICOR HCV Tests are indicated for patients who have evidence of liver disease and antibody evidence of HCV infection and who are suspected to be actively infected with HCV. Detection of HCV RNA is evidence of active HCV infection but does not distinguish between acute and chronic states of infection.

"We are pleased that the FDA realizes the significance of the hepatitis C epidemic by announcing their decision. The Amplicor HCV Test is accurate and reliable for detecting the presence of HCV RNA," Dave Thomas, Vice President for Regulatory Affairs, Roche Diagnostics. "We are committed to developing the most advanced technologies for better treatment and testing options for the millions of people affected by this epidemic."

Roche's AMPLICOR HCV Tests utilize Nobel Prize-winning Polymerase Chain Reaction (PCR) technology to directly detect the hepatitis C viral RNA. In addition, the AMPLICOR HCV Tests are the first HCV RNA assays to report the analytical sensitivity in International Units (IU/mL), as defined by the WHO International Standard for HCV RNA for Nucleic Acid Amplification Technology (NAT) Assays.

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver, is a leading cause of cirrhosis and liver cancer and the number-one reason for liver transplants in the U.S. An estimated 4.4 million Americans have the virus and an estimated 2.7 million of them have chronic hepatitis C infection. There are approximately 35,000 new infections each year. In the United States, the Centers for Disease Control and Prevention estimate that hepatitis C is responsible for eight to ten thousand deaths per year. This figure could increase to 38,000 deaths per year by 2010.

Hepatitis C is transmitted through body fluids, primarily blood or blood products, and sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people who are infected with hepatitis C are unaware of it because it may take years for symptoms to develop.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people's well-being and quality of life. Roche has approximately 65,000 employees and sells its products in over 170 countries. Through the company's Diagnostics Division, innovative testing products and services are made available to physicians, patients, hospitals and laboratories worldwide. Roche Diagnostics Corporation, based in Indianapolis, is the North American headquarters for the diagnostics business of the company.