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FDA Approves First Hepatitis B Viral Load Test
Date:9/4/2008

s in the U.S.

Other infections concomitant with Hepatitis B are common, with up to 10% of HIV patients in the US also infected with Hepatitis B virus. This makes it essential for the test to quantitate the HBV virus in presence of other viruses.

Designed for use with the High Pure System, the test is run on the COBAS(R) TaqMan(R) 48 analyzer and gives labs the added benefits of automated real-time PCR. The test system benefits from the same contamination control protection designed into all COBAS(R) TaqMan(R) assays, including closed-tube processing and built-in Roche-proprietary AmpErase enzymes. To help with needed standardization, the Roche COBAS(R) TaqMan(R) HBV Test has been calibrated with the WHO standard and reports with the international unit of measure IU/mL. The test was designed to quantify all major Hepatitis B genotypes, including pre-core mutants that can lead to more severe liver disease and reduced response to antiviral therapy.

Roche Diagnostics, a leader in molecular diagnostics, has more than 10 years of global experience in HBV viral load testing and has actively monitored virus mutation through its Global Surveillance program. The COBAS(R) TaqMan(R) HBV Test is the latest in a portfolio of increasingly automated real-time PCR Hepatitis and HIV tests that Roche is developing. The company's fully automated, real-time HIV monitor test was approved by the FDA in May 2007 and the company has filed a Premarket Approval Application for its test to quantitate HCV virus RNA.

About Hepatitis B

According to the World Health Organization, HBV is the most serious type of viral hepatitis infecting 2 billion people each year and representing a serious public health problem. Even with a Hepatitis B vaccine, which has been available since 1982, the U.S. Centers for Disease Control estimates that 1.25 million people are living with chronic Hepatitis B infection. Another 60,000 people become newly infected each year and 5,000 pe
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