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

Core Insights - The company has completed its first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument and the Co-Dx PCR COVID-19 Test for OTC use, marking a significant milestone in its growth [8] - The company plans to pursue POC clearance for the Co-Dx PCR COVID-19 test shortly, with additional tests in development to cater to a global market [1][2] - The Co-Dx PCR platform aims to decentralize access to gold-standard PCR diagnostics, traditionally available only in high-complexity laboratories, by enabling point-of-care and at-home testing [9] Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company that develops, manufactures, and markets advanced diagnostic technologies, focusing on nucleic acid detection and analysis [5] - The company utilizes proprietary technology to create specific tests for its Co-Dx PCR platform, which includes at-home and point-of-care applications [5] Product Development - The Co-Dx PCR platform includes various components such as the PCR Home™, PCR Pro™, and a mobile app, all of which are currently under FDA review [4] - Other diagnostics in development include tests for tuberculosis, human papillomavirus, strep A, and a multiplex respiratory test that detects influenza A and B, COVID-19, and RSV [10] - The company anticipates that the upcoming tests will be transformative and is actively working to complete clinical evaluations and regulatory submissions for these products [11]