Cleo Diagnostics to Complete US Trial, Advance US FDA Submission in 2026; Shares Down 3%

MT Newswires Live

2025/12/29

Cleo Diagnostics (ASX:COV) said the company is set to complete its US clinical trial, advance to Food and Drug Administration (FDA) 510(k) submission, and start commercial manufacturing of its ovarian cancer detection product in 2026, according to a Monday filing with the Australian bourse.

The company said it will also focus on the development of its mass screening program.

Shares fell past 3% in afternoon trade Monday.

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