Roche has secured the US Food and Drug Administration (FDA) approval for its cobas MPX test to be used on the cobas 6800 and 8800 Systems.
The cobas MPX test allows donor screening laboratories to apply PCR-based diagnostic technology to the surveillance of donated blood and plasma in the US, 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.
Roche molecular diagnostics head Uwe Oberlaender said: "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.
"We will continue to partner with donor screening laboratories worldwide demonstrating our joint commitment to patient safety."
The cobas MPX is a nucleic acid test developed to detect HIV, HBV and HCV in human blood plasma and serum.
The real-time time PCR multiplex test can detect five critical viral targets which are HIV-1 Group M, HIV-1 Group O, HIV-2, HBV and HCV from a single sample.
cobas MPX assay works with a dual-target approach with amplification of separate regions of HIV-1, and dual probes for HCV by eliminating the requirement for discriminatory testing between HIV, HBV, and HCV and the potential for discrepant results.
The cobas 6800 and cobas 8800 Systems are fully integrated, automated solutions facilitating molecular testing for donor screening, viral load monitoring, women's health and microbiology.
The systems are based on PCR technology, and are designed to deliver fully automated solutions with increased throughput and faster turnaround time, thereby boosting workflow efficiencies.