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FDA Approves Use of Roche Test to Screen Source Plasma for HIV, Hepatitis B Virus and Hepatitis C Virus
Date:12/2/2009

tine NAT testing, which can detect HIV-1 and HCV in the early stages of infection, has reduced the risk of transfusion-transmitted HIV-1 and HCV infections to negligible levels. The importance of hepatitis B virus in transfusion-transmitted diseases is increasingly being recognized and NAT screening for HBV is being implemented in some countries.

The cobas® TaqScreen MPX Test runs on the fully automated, real-time PCR cobas s 201 system, designed to increase processing efficiency with a unique modular design and ready-to-use reagents.

The cobas s 201 system has the capability of running multiple channels using multi-dye technology, enabling simultaneous detection of several viruses. Roche is developing another multi-dye assay on the same platform, the cobas® TaqScreen DPX test, that is designed to simultaneously provide a quantitative result for B19 virus and a qualitative result for hepatitis A virus.

"As a stand-alone PCR system the cobas s 201 system and cobas® TaqScreen MPX Test for HBV, HIV and HCV, provides a simple user interface while improving process control and lab efficiencies," said Douglas Lee, PhD, Sr. Director Pathogen Safety and Research, Talecris Biotherapeutics, one of the largest fractionators in the US and a clinical trial site for the cobas® TaqScreen MPX Test.

About Roche Blood Screening

Roche Diagnostics is the leading provider of real-time PCR-based nucleic acid tests for the international blood bank market. Nucleic acid-based tests enable earlier detection of active HIV, hepatitis C and hepatitis B infections than conventional antibody or antigen assays. Roche assays have been used since 1999 to screen blood and plasma products. Roche launched the automated cobas s 201 system and the cobas® TaqScreen MPX Test outside the United States in 2006 for the most comprehensive single-assay detection of HIV-1 Groups M & O, HIV-2,
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SOURCE Roche Molecular Systems, Inc.
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