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Cleo Diagnostics Ltd (ASX:COV)

ALERT: Price-sensitive ASX Announcement for COV
Current share price for COV : $0.495 0.12 (32%)+
Announcement
Release
15 Sep 2025 9:30AM
Price at Release
$0.375
Full Release
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Summary
Cleo Diagnostics Ltd has announced that it received positive feedback from the U.S. FDA during its second pre-submission meeting for its Ovarian Cancer Pre-Surgical Triage Test. The FDA's guidance supports CLEO's clinical trial design and aligns with regulatory expectations, which is expected to reduce the regulatory risk ahead of its 510(k) submission. Cleo's CEO, Dr. Richard Allman, emphasized that the FDA feedback is a significant milestone, allowing the company to refine its trial design and proceed with confidence towards delivering a meaningful solution for ovarian cancer surgical triage.
Key Points
  • Cleo received positive FDA feedback on its Ovarian Cancer Test.
  • FDA supports CLEO's clinical trial design and regulatory positioning.
  • Positive FDA feedback reduces regulatory risk for 510(k) submission.
  • The meeting focused on clinical trial design and sample stability.
  • CLEO aims to deliver a clinically meaningful solution for ovarian cancer.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.