February 14, 2023 – Cepheid announced it has received Emergency Use Authorization from the FDA for Xpert Mpox, which runs on Cepheid’s GeneXpert® systems. The EUA is supported by the Secretary of Health and Human Service’s declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of infection with the monkeypox virus.
Xpert Mpox is authorized for use in moderately complex settings and is considered authorized for use in point of care (POC) settings under the EUA for use on GeneXpert Xpress systems. The test can be used in settings operating under a CLIA Certificate of Waiver (CoW), Certificate of Registration (CoR), Certificate of Accreditation (CoA), or Certificate of Compliance (CoC).
“Thankfully, the threat of mpox in the United States has decreased dramatically since last summer. However, it is still circulating in many parts of the world making it important for healthcare providers to be ready for its potential re-emergence,” said David Persing M.D., Ph.D., EVP and Chief Scientific Officer of Cepheid. “Xpert Mpox runs on Cepheid’s GeneXpert systems, which has the largest installed base of any PCR-based molecular diagnostic platform, making this new test a valuable component within a preparedness plan that could be deployed quickly wherever accurate and actionable information is needed.”