Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx PCR Platform to Support Submission to the U.S. FDA
Co-Diagnostics has started clinical performance testing for its Co-Dx PCR Flu A/B, COVID-19, RSV Test Kit on the Co-Dx PCR Pro instrument.
The evaluations aim to support a U.S. FDA 510(k) submission for the upper respiratory multiplex point-of-care test.
Results may also support regulatory submissions to other authorities, including the Saudi Food and Drug Authority.
The company plans to introduce the test in India via its joint venture, CoSara Diagnostics.
The Co-Dx PCR platform is currently under regulatory review and not yet available for sale.
Commercialization depends on successful clinical results and regulatory clearance.