Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform

On June 14, 2024, Co-Dx announced that it has completed its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx™ PCR Pro™ instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use.  The Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the pipeline to meet the needs of a global market. The Co-Dx PCR platform has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories. It consists of a compact and robust real-time PCR instrument operated at point-of-care or in at-home settings via an intuitive smartphone interface, with test cups powered by patented Co-Dx Co-Primers® technology.