Co-Diagnostics completes submission on Co-Dx PCR Pro to FDA

Co-Diagnostics has submitted its Co-Dx PCR COVID-19 test with Co-Dx PCR Pro instrument for review by the U.S. Food and Drug Administration for Emergency Use Authorization. The submission includes the PCR Pro instrument, COVID-19 detection test, and mobile app, all designed for use in point-of-care and at-home settings. Tests run on the new platform use the Company’s patented real-time polymerase chain reaction Co-Primers technology. The Co-Dx COVID-19 test kit for the PCR Pro instrument included in the Company’s FDA submission has been shown in clinical evaluations to detect the presence of COVID-19 in anterior nasal swab samples, with results displayed on the user’s smartphone or mobile device in approximately 30 minutes.