FDA Grants EUA for Roche’s Cobas MXPV Monkeypox PCR Test

The FDA has granted Emergency Use Authorization (EUA) for Roche’s cobas MXPV monkeypox real-time polymerase chain reaction (PCR) assay for use on cobas 6800/8800 systems.

The assay targets two regions of the monkeypox virus genome less prone to mutations, detecting the virus even if a mutation occurs in one of the target regions. The test delivers results quickly, so patients are not subjected to unneeded isolation or additional testing, the company said.

The cobas 6800/8800 systems authorized for use with the assay are high-volume automated systems that can provide results in three and a half hours.