Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance

Core Viewpoint - Co-Diagnostics, Inc. has withdrawn its 510(k) application for the Co-Dx™ PCR COVID-19 Test based on FDA feedback regarding shelf-life stability, opting to submit an enhanced version of the test instead [1][3]. Group 1: FDA Interaction and Submission Withdrawal - The decision to withdraw the submission was made after discussions with the FDA concerning the detection of potential deterioration of a test component related to shelf-life stability [3]. - Co-Diagnostics expressed satisfaction with the productive engagement with the FDA regarding the initial regulatory submission and the test's performance in clinical evaluations [2][3]. Group 2: Future Plans and Enhancements - The company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance after collecting clinical evaluation data to support the new test's performance [4]. - The new submission will allow the incorporation of recent developments in the Co-Dx PCR platform, aiming to enhance operational and manufacturing efficiencies [4]. - Co-Diagnostics aims to execute a robust development and commercialization plan for the Co-Dx PCR platform, with additional tests for tuberculosis, upper-respiratory multiplex, and multiplex HPV tests expected to follow [5]. Group 3: Company Overview - Co-Diagnostics, Inc. is a molecular diagnostics company that develops, manufactures, and markets advanced diagnostic technologies, utilizing proprietary technology for tests designed to detect and analyze nucleic acid molecules [7].