Co-Diagnostics withdraws 510k application to FDA for Co-Dx PCR COVID-19 Test

Co-Diagnostics (CODX) announced that, following a collaborative and informative dialogue with the Food and Drug Administration, the company has withdrawn its 510(k) application to the FDA for its Co-Dx PCR COVID-19 Test on the PCR Pro, in favor of submitting an enhanced version of the test for 510(k) clearance. Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument. The decision by the company to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process. The company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test’s performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help to create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform.