FDA Approves Roche cobas MPX Test for Blood Donors

FDA has approved a Roche PMA for the cobas MPX test for use on the cobas 6800 and 8800 Systems. The 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,” the company says. “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,” it says.  Earlier this year, Roche began testing for Zika virus at U.S. blood centers under an IDE protocol with the cobas Zika test for use with the 6800/8800 systems.