Molecular diagnostics company Co-Diagnostics Inc (Nasdaq: CODX) disclosed on Monday that it has completed clinical and analytical performance studies supporting its planned FDA submission for the Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro platform.

The studies included more than 1,400 patients across nine clinical sites, alongside extensive analytical validation comprising 27 studies and over 10,000 PCR test cup runs. The company said the data will support a dual 510(k) and CLIA Waiver by Application submission, targeted for the third quarter of 2026.

Co-Diagnostics said the results demonstrate consistent performance across multicentre reproducibility testing, including operation by untrained users, and form a key milestone ahead of regulatory review for use in point-of-care settings.