Subject: FDA
Cepheid Receives Emergency Use Authorization from FDA for Xpert® Mpox
First Point-of-Care Test for Mpox
SUNNYVALE, Calif., Feb. 14, 2023 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration 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."
One of the key signs of infection with the monkeypox virus is fever with development of a maculopapular rash, often appearing as small, raised spots. However, there are many other illnesses, such as chickenpox, measles, bacterial skin infections, syphilis, herpes, and medication-associated allergies that can present with similar symptoms. The World Health Organization recommends that suspected cases of mpox be confirmed with a PCR test run on an appropriate human lesion sample1.
Globally, there is an installed base of almost 50,000 GeneXpert systems in 180 countries. Xpert Mpox is expected to begin shipping in the U.S. by the end of February. For more information on Cepheid's GeneXpert systems or the complete menu of Xpert tests, visit www.cepheid.com.
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About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
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