November 28, 2022 – Roche (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for cobas® MPXV for use on the cobas® 6800/8800 Systems.
The test is a real time PCR test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection by their healthcare provider. cobas MPXV targets two different regions of the MPXV genome, which are both less prone to mutations than other parts of the genome. This dual-target approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions.
The company says that the high-throughput solution can help individuals get the right results quickly. This is important so that patients are not subjected to unnecessary additional testing or isolation, and will have access to appropriate treatment as soon as possible.