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Cleo Diagnostics Ltd (ASX:COV)

ALERT: Price-sensitive ASX Announcement for COV
Current share price for COV : $0.335 -0.2 (-37.38%)+
Announcement
Release
31 Mar 2026 9:04AM
Price at Release
$0.535
Full Release
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Summary
Cleo Diagnostics Ltd (ASX:COV) has announced the successful completion of its sample collection for a pivotal U.S. clinical trial involving its Pre-Surgical Ovarian Cancer Test. With 514 blood samples collected from 624 enrolled women across 19 sites, the company has reached a key milestone towards its FDA submission. This trial is crucial for evaluating the test's efficacy in distinguishing benign from malignant ovarian growths. The company is progressing towards the final stages of execution, including analytical validation, clinical sample testing, and data analysis for FDA 510(k) submission. A binding agreement for test kit production is also nearing completion following biomarker panel optimization.
Key Points
  • 514 blood samples collected for CLEO's clinical trial.
  • 624 women enrolled across 19 U.S. sites.
  • Target achieved for FDA submission for Pre-Surgical Ovarian Cancer Test.
  • Clinical trial designed for women with adnexal mass.
  • Biomarker panel optimization completed.
  • Pre-verification and analytical validation next steps.
  • Clinical sample testing to commence using CLEO test kit.
  • Clinical data analysis for FDA 510(k) submission.
  • Samples stored under controlled conditions prior to surgery.
  • Binding manufacturing agreement in final stages.
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.