Co-Diagnostics, Inc. announced that it 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 (FDA) for Emergency Use Authorization (EUA).

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 (PCR) 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. The menu of future tests that are currently in development for the new platform includes tuberculosis (TB) and human papillomavirus (HPV), as well as an upper respiratory multiplex panel that will detect influenza A/B, COVID-19, and respiratory syncytial virus (RSV) within a single sample. All three tests have also been the subject of grant support by notable funding bodies over the last half of this year.