Roche receives U.S. FDA EUA for its test to detect monkeypox virus

Nov. 21, 2022
Update from Roche.

Roche 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.

Roche release