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Roche Receives FDA Emergency Use Authorization For Its Test To Detect Monkeypox Virus

The U.S. Food and Drug Administration granted Emergency Use Authorization 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 or MPXV in lesion swabs collected from individuals suspected of monkeypox infection by their healthcare provider, Roche (RHHBY) said in a statement on Wednesday.

cobas MPXV targets two different regions of the MPXV genome, which are both less prone to mutations than other parts of the genome. The dual-target approach ensures that cobas MPXV will continue to detect the virus even if a mutation occurs in one of the target regions.

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