The U.S. Food and Drug Administration (FDA) on Friday granted an emergency use authorization (EUA) for the Cepheid Xpert Mpox test for use in a point-of-care setting.
The Xpert Mpox test is a real-time polymerase chain reaction (PCR) assay to detect Mpox virus DNA in lesion swab specimens from individuals suspected of having monkeypox by their healthcare provider.
Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program established as a collaboration between the FDA and the NIH.
The EUA is the latest example of the FDA’s ongoing commitment to advance greater consumer access to tests for infectious diseases, the agency said.
