Cleo Diagnostics (ASX:COV) received positive feedback from the US Food and Drug Administration (FDA) at the second pre-submission meeting for its ovarian cancer pre-surgical triage test, according to a Monday filing with the Australian bourse.
The feedback will help the company improve the robustness of its clinical trial design by strengthening data collection processes for a high-quality submission, the filing said.
Shares rose 9% in midday trade Monday.