US FDA grants EUA for Cepheid Xpert Mpox test for use in a point-of-care setting
The US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for the Cepheid Xpert Mpox test for use in a point-of-care setting. Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Programme established as a collaboration between the FDA and the NIH. 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. The EUA is the latest example of the FDA
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