EXCLUSIVE: Co-Diagnostics Reaches Regulatory Milestone for PCR Respiratory Test Platform - Co-Diagnostics

Co-Diagnostics Inc.

(NASDAQ:CODX) on Wednesday said it completed clinical and analytical performance studies for the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument.

Completes Studies For PCR Respiratory Test The molecular diagnostics company currently expects to include the studies in its planned submission package.

The update on these studies represents a significant milestone in preparation for a Dual 510(k) and CLIA Waiver by Application submission to the U.S.

Food and Drug Administration (FDA), targeted for the third quarter of 2026.