NEW YORK – Co-Diagnostics announced Friday that it has withdrawn a 510(k) submission to the US Food and Drug Administration for a COVID-19 assay on its portable PCR instrument.
Co-Diagnostics' Co-Dx PCR COVID-19 assay runs on its PCR Pro instrument for at-home and point-of-care testing and was originally submitted to the FDA in June 2024.
In a statement, the Salt Lake City-based diagnostics developer said that the decision to withdraw the submission followed "a collaborative and informative dialogue" with the FDA and was motivated by questions about the ability to detect deterioration of a test component related to shelf-life stability.
Co-Diagnostics plans to eventually submit an enhanced version of its test for over-the-counter 510(k) clearance, which it said will allow it to incorporate more recent platform developments, as well. These steps will improve operational and manufacturing efficiencies, the firm said, in part by 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.
The Co-Dx PCR COVID-19 test is expected to be followed by additional tests, including multiplex upper respiratory, multiplex human papillomavirus, and an assay for tuberculosis.