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Roche Receives FDA Approval for Fully Automated Blood Screening Assay

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Roche has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas® MPX test for use on the cobas® 6800 and 8800 Systems. The cobas® MPX test enables donor screening laboratories to apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the spread of Human Immunodeficiency Virus Groups 1 and 2 (HIV-1 and HIV-2), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)through transfused blood products.

“This approval reinforces our strong presence in donor screening, and underscores our ability to provide proven, robust technology for the testing of donated blood and blood products,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics. “We will continue to partner with donor screening laboratories worldwide demonstrating our joint commitment to patient safety.”

The fully automated cobas® 6800/8800 Systems offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing blood and plasma screening laboratories with improved operating efficiency and flexibility to adapt to changing testing demands. Earlier this year, Roche initiated testing for Zika virus at U.S. blood centers under FDA Investigational New Drug Application protocol with the cobas® Zika test for use with the cobas® 6800/8800 Systems.