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Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform
Date:10/30/2008

ults-out capability. The platform is flexible and customizable to meet the space and workflow needs of any laboratory. In the United States, more than 130 laboratories already utilize this fully automated platform for HIV testing.

The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HCV Test is the third Roche COBAS(R) TaqMan(R) real-time PCR test approved by the FDA in the last eighteen months. The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System menu includes an FDA approved HIV viral load test, with continuous loading of samples in addition to parallel processing of HIV and HCV tests. In September 2008, Roche received FDA approval of the COBAS(R) TaqMan(R) HBV Test to monitor Hepatitis B viral load in patients on therapy.

About Hepatitis C

According to the Centers for Disease Control and Prevention, each year in the U.S. approximately 8,000-10,000 people die from hepatitis C-related liver disease.

An estimated 3.2 million persons in the United States have chronic hepatitis C virus infection. Most people do not know they are infected because they don't look or feel sick. However, approximately 75%-85% of people who become infected with hepatitis C virus develop chronic infection. (1)

Hepatitis C infections can range in severity from a mild or "acute" illness lasting a few weeks to a serious, lifelong or "chronic" illness. For most people, acute infection leads to chronic infection. Chronic hepatitis C infection is a serious disease that can result in long-term health problems, including liver damage, liver failure, liver cancer, or even death. Hepatitis C is the leading cause of cirrhosis and liver cancer and the most common reason for liver transplantation in the United States.

Hepatitis C virus is passed from person to person when infected blood enters the body of someone who is not infected. Different ways people can be infected with the hepatitis C virus include sharing contaminated needles, high risk sex with an infected partner
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SOURCE Roche Molecular Diagnostics
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