Amid the coronavirus pandemic, the U.S. Food and Drug Administration (FDA) has approved the first rapid COVID-19 coronavirus diagnostic test, with a detection time that only takes about 45 minutes.
Sunnyvale, California-based Cepheid today announced it has received Emergency Use Authorization (EUA) 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. 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 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, in a statement. “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 in a statement. “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.”
The test will begin shipping next week. For more information about Cepheid’s Xpert Xpress SARS-CoV-2 test, please visit www.cepheid.com/coronavirus.
Cepheid is a leading molecular diagnostics company that is an operating company within Danaher Corporation’s Diagnostics platform.
MacDailyNews Take: This rapid coronavirus test is a major improvement over the current testing regime where results can take days, since samples must be sent to a centralized lab.