NEW YORK (GenomeWeb) – Roche announced today that it has received approval from the US Food and Drug Administration for its Cobas MPX test, a nucleic acid test for the detection of HIV, hepatitis B, and hepatitis C in human blood plasma and serum.
The assay, which is approved for use on the company's Cobas 6800 and 8800 systems, allows screening labs in the US to use advanced PCR-based diagnostic technology to screen donated blood and plasma, to prevent the spread of HIV-1 and HIV-2, HBV, and 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," Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement. "We will continue to partner with donor screening laboratories worldwide demonstrating our joint commitment to patient safety."
The Cobas 6800 and 8800 molecular diagnostic platforms and associated hepatitis B and hepatitis C viral load assays received FDA approval in October 2015.