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Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test

By LabMedica International staff writers
Posted on 24 Mar 2020
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Image: FDA EUA issued for Xpert Xpress SARS-C-oV-2 (Photo courtesy of Cepheid)
Image: FDA EUA issued for Xpert Xpress SARS-C-oV-2 (Photo courtesy of Cepheid)
Cepheid (Sunnyvale, CA, USA) has received Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) for Xpert Xpress SARS-CoV-2, its rapid molecular diagnostic test for the qualitative detection of SARS-CoV-2, the virus causing COVID-19. The test has a detection time of approximately 45 minutes and has been designed to operate on any of Cepheid's more than 23,000 automated GeneXpert Systems worldwide.

Cepheid is a molecular diagnostics company that develops, manufactures, and markets accurate, easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions allow institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. The company focuses on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer.

Cepheid’s automated molecular test for the qualitative detection of SARS-CoV-2 leverages the design principles of its current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted. The test can provide rapid detection of the current pandemic coronavirus SARS-CoV-2 in approximately 45 minutes with less than a minute of hands on time to prepare the sample. The Xpert Xpress SARS-CoV-2 can be utilized in multiple settings where actionable test results are needed to make informed treatment decisions quickly. The test delivers point-of-care results with the same level of performance seen in reference labs.

"During this time of increased demand for hospital services, Clinicians urgently need an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. An accurate test delivered close to the patient can be transformative — and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities that need to properly allocate their respiratory isolation resources," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "By leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly."

"Cepheid currently has nearly 5,000 GeneXpert Systems in the US capable of point-of-care testing and for use in hospitals," said Cepheid President Warren Kocmond. "Our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today."

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