FDA Approves Roche’s Monkeypox Test

The US Food and Drug Administration (FDA) issued an emergency use authorization to Roche’s test for the detection of DNA from the monkeypox virus.

The test developed by the Swiss company will be used for the detection of DNA from the monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox virus by their health care provider.

According to the FDA, testing will be limited to laboratories that meet the requirements to perform moderate or high-complexity tests.

The Biden administration declared the monkeypox outbreak a public health emergency in October. To date, 28,999 confirmed cases and 11 deaths have been reported in the US, the Centers for Disease Control and Prevention data shows.


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