Co-Diagnostics, Inc. announced that it has commenced clinical evaluations for its at-home and point-of-care Co-Dx PCR Home(TM) 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.

It is the culmination of a development process that spans over two years of research and development and has harnessed the expert skills of well over a hundred dedicated scientists, engineers, and support staff. The new at-home and point-of-care testing (POCT) platform represents a high degree of innovation that brings together the power of patented Co-Primer(TM) technology coupled with other proprietary IP, setting a new standard for compact POCT that unlocks the multiplexing potential of real-time PCR.