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Emergency Approval Granted for Cepheid’s Rapid Results COVID-19 Test
Sunnyvale, CA-based Cepheid received Emergency Use Authorization from the U.S. Food & Drug Administration (FDA) for Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19. Cepheid’s test is reportedly the first test approved for coronavirus that can be done bedside and get results in less than an hour. Previously, test results could take several days.
The test has been designed to operate on any of Cepheid’s more than 23,000 automated GeneXpert Systems worldwide, with a detection time of approximately 45 minutes. The company said tests will begin shipping this week.
Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid, says, “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.”
Cepheid President Warren Kocmond noted that Cepheid currently has nearly 5,000 GeneXpert Systems in the U.S. capable of point-of-care testing and for use in hospitals. He added, “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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