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Roche Receives FDA Approval for Second-Generation Hepatitis B Viral Load Test
Date:9/22/2010

ume of 650 uL of either serum or plasma specimens and is standardized against the World Health Organization (WHO) Standard for hepatitis B.

This test is designed for use on Roche's fully automated COBAS® AmpliPrep/COBAS® TaqMan® System that is used in more than 250 clinical laboratories across the U.S.

The platform combines the COBAS® AmpliPrep Instrument for automated sample preparation and the COBAS® TaqMan® Analyzer or the smaller COBAS® TaqMan® 48 Analyzer for automated real-time PCR amplification and detection.

"Sample in/results out" testing eliminates manual intervention between steps and configuration options allow for customizable solutions for throughput needs. For a flexible throughput solution, the test offers 72 tests per kit in self sealing, ready-to-use reagent cassettes. Roche's proprietary AmpErase enzymes are also included in each test and are designed to prevent cross-contamination of samples and labs.

About Hepatitis B Approximately 4,500 cases of acute hepatitis B in the United States are reported to CDC each year and each year an estimated 43,000 persons are newly infected with HBV.(1) However, because many HBV infections are either asymptomatic or never reported, the actual number of new infections is estimated to be approximately tenfold higher.  

The hepatitis B virus is spread through having unprotected sex, by sharing needles, or from an infected mother to her baby during child birth. Symptoms occur in about 70 percent of patients and include jaundice, fatigue, abdominal pain, loss of appetite, nausea and vomiting.  

About RocheHeadquartered 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
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SOURCE Roche Molecular Diagnostics
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