November 5, 2024- Cepheid announced that The World Health Organization (WHO) has listed Xpert Mpox under its Emergency Use Listing (EUL) procedure. The EUL process assesses the quality, safety, and performance of essential health products, such as diagnostic tests, to guide procurement agencies and WHO Member States in making informed decisions for time-limited emergency procurement.
In February 2023, Xpert Mpox was the first point-of-care test to receive Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for the detection and/or diagnosis of mpox infection. Polymerase Chain Reaction (PCR) testing, which detects viral DNA, is considered the gold standard for diagnosing mpox infection1. Xpert Mpox on the GeneXpert Systems provides results for mpox clade II and for non-variola Orthopoxviruses (including mpox clade I and II) from lesion swabs. Results are available in less than 40 minutes, and the test can be performed in decentralized near-patient settings.