Co-Diagnostics Completes EUA Submission To FDA For Co-Dx PCR Pro

(RTTNews) - Co-Diagnostics, Inc. (CODX) Wednesday 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.