Cepheid announced today that it received CE mark approval for its Xpert Xpress CoV-2/Flu/RSV Plus rapid molecular diagnostic.
Sunnyvale, California-based Cepheid last month received FDA emergency use authorization (EUA) for the Xpert Xpress CoV-2/Flu/RSV Plus diagnostic.
The company designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV). According to a news release, test results are made available after about 36 minutes.
Cepheid noted that the addition of a third gene target to the Plus version of the Xpert Xpress diagnostic platform offers more coverage to mitigate the potential effects of future viral genetic drift as variants of COVID-19 continue to develop.The company expects to begin shipping the newly approved test to countries accepting CE-marked products this month.
“During this time of year, healthcare provid…