Original from: Medical Device Network
The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the Xpert Mpox test from molecular diagnostics company Cepheid.
The authorisation enables the emergency use of in vitro diagnostics for the detection and diagnosis of infection with the monkeypox virus, which is supported by a declaration from the Secretary of Health and Human Services.
Designed to operate on the company¡¯s GeneXpert systems, the test has received authorisation for use in moderately complex settings.
Under the EUA, Xpert Mpox is now authorised for use in point-of-care (POC) settings on the GeneXpert Xpress systems.
The test provides flexibility by being approved for use in settings operating under a CLIA Certificate of Waiver (CoW), Certificate of Registration (CoR), Certificate of Accreditation (CoA), or Certificate of Compliance (CoC), stated Cepheid.
The company is planning to commence shipping of the test in the US by the end of the month.
Cepheid chief scientific officer and executive vice-president David Persing said: ¡°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.
¡°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.¡±
Last May, Cepheid secured EUA from the FDA for its Xpert Xpress CoV-2 plus test, which can identify the virus that causes Covid-19.
