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Roche Receives FDA Emergency Use Authorization for Cobas Monkeypox Test

NEW YORK – The US Food and Drug Administration said on Tuesday that it has granted Emergency Use Authorization for Roche's molecular monkeypox test. 

The RT-PCR test, which qualitatively detects DNA from monkeypox virus in human lesion swab specimens, runs on the Cobas 6800/8800 systems. It is intended for use at moderate- and high-complexity labs and authorized for use in people suspected of monkeypox virus infection by their healthcare provider, the FDA said in a statement. 

The agency began issuing EUAs for monkeypox tests in September after the US Department of Health and Human Services declared a public health emergency for the virus in August. Quest Diagnostics obtained EUA for its monkeypox test in September, while Abbott received EUA for its test last month.