The FDA has approved Roche’s cobas MPX test for use on the cobas 6800 and 8800 systems, according to a news release from the company.
The cobas MPX is a nucleic acid test for the detection of HIV, hepatitis B virus and hepatitis C virus in blood plasma and serum.
According to the release, it will allow donor screening laboratories in the United States to apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma.
“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, PhD, head of Roche Molecular Diagnostics, said in the release. “We will continue to partner with donor screening laboratories worldwide demonstrating our joint commitment to patient safety.”
Disclosure: Oberlaender works for Roche.