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FDA Authorizes Mpox Test Based on Data from the NIH Independent Test Assessment Program

Recently, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first mpox test for use in a point-of-care (POC) setting. Validation data to support the EUA for the Cepheid Xpert Mpox test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. This EUA is the latest example of the FDA’s ongoing commitment to advance greater consumer access to tests for infectious diseases.

The Xpert Mpox test is a real-time polymerase chain reaction (PCR) test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider.

Questions?

If you have questions about this authorization, contact MPXDx@fda.hhs.gov.