FDA Approves 45-Minute Point-of-Care COVID-19 Test; First Rapid, Near-Patient Molecular Test for Detection of Virus that Causes COVID-19 Developed by California’s Cepheid

On March 21, 2020, California-based Cepheid announced that it has received Emergency Use Authorization (EUA) from the FDA for its Xpert® Xpress SARS-CoV-2, a rapid 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 with less than a minute of hands on time to prepare the sample. "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, 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 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.