FDA grants emergency use authorisation for Xpert Xpress SARS-CoV-2 test for coronavirus.- Cepheid

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 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. The test will begin shipping next week.

Comment: The company has leveraged the design principles of the Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and future pandemic coronavirus strains.