On Feb. 10, 2023, 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 setting.

Validation data to support the EUA for the Cepheid Xpert Mpox test was gathered through the National Institutes of Health Independent Test Assessment Program established as a collaboration between the FDA and the NIH.

The Xpert Mpox test provides on-demand testing with point-of-care results in approximately 36 minutes. This allows healthcare providers to address the care needs and treatment for their patients on the same day.