Co-Diagnostics has commenced clinical evaluations for its at-home and point-of-care Co-Dx PCR Home platform and initial COVID-19 test, consisting of the clinical trials and analytical studies that are expected to support submissions to the United States FDA and other regulatory bodies. The Company’s real-time PCR platform has been developed for detection of infectious diseases in at-home and point-of-care settings, with anticipated multiplex panels to follow after receipt of the platform’s initial regulatory authorization. Because the evaluations are dependent on identifying and enrolling a particular number of both symptomatic and asymptomatic COVID-19-positive and -negative patients at testing sites, the Company will not be providing projected timelines for completion at this time.
Published first on TheFly
