Cepheid announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert Xpress SARS-CoV-2, a rapid point-of-care (POC) molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19. 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.
"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 healthcare 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, PhD, 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 President Warren Kocmond added, "Cepheid currently has nearly 5,000 GeneXpert systems in the U.S. capable of point-of-care testing and for use in hospitals. 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."
