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Cleo Diagnostics Ltd (ASX:COV)

ALERT: Price-sensitive ASX Announcement for COV
Current share price for COV : $0.320 -0.305 (-48.80%)+
Announcement
Release
29 Apr 2026 9:32AM
Price at Release
$0.625
Full Release
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Summary
Cleo Diagnostics Ltd, trading on the ASX under the ticker COV, provided its quarterly report for the quarter ending 31 March 2026. The company has made significant progress in its pivotal U.S. clinical trial, collecting over 500 samples needed for its 510(k) FDA submission. Cleo selected Bio-Techne’s Ella™ platform for its ovarian cancer blood test, which offers faster results and enhanced analytical capabilities. The company also optimized its biomarker panel to include eight markers, enhancing robustness and manufacturability. Cleo has commenced a manufacturing program with Bio-Techne to produce clinical-grade test kits ahead of its FDA submission. Financially, Cleo ended the quarter with cash reserves of A$7.8 million, indicating it is well-funded to pursue its clinical and regulatory milestones.
Key Points
  • Completion of pivotal U.S. clinical trial sample collection for FDA submission.
  • Selection of Bio-Techne’s Ellaâ„¢ platform for ovarian cancer test.
  • Biomarker panel expanded to eight markers for commercial readiness.
  • Commencement of manufacturing program with Bio-Techne.
  • Cash reserves of A$7.8 million as of 31 March 2026.
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.