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Cleo Diagnostics Ltd (ASX:COV)

ALERT: Price-sensitive ASX Announcement for COV
Current share price for COV : $0.510 -0.1 (-16.39%)+
Announcement
Release
18 Feb 2026 9:44AM
Price at Release
$0.610
Full Release
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Summary
Cleo Diagnostics Ltd (ASX:COV) has announced the selection of Bio-Techne's Ella™, a next-generation automated ELISA platform, to deliver its ovarian cancer blood test. The Ella™ platform offers improved assay sensitivity, precision, and automation compared to traditional ELISA platforms, which is crucial for measuring CLEO's proprietary biomarker panel. The company has been using the Ella™ platform internally since September of the previous year and is progressing towards a binding agreement with Bio-Techne for analytical validation of its test kits. The kits are intended for use in a pivotal clinical trial involving approximately 500 blood samples, and the results are expected to support CLEO's FDA 510(k) submission. Both companies plan to enter a long-term commercial supply agreement upon successful trial completion.
Key Points
  • Cleo selects Bio-Techne’s Ella™ platform for ovarian cancer test delivery.
  • Ella™ platform provides improved assay sensitivity, precision, and automation.
  • CLEO has been using Ella™ since September last year.
  • Progress towards a binding agreement with Bio-Techne for analytical validation.
  • Ella™ platform to be used in pivotal clinical trial with ~500 blood samples.
  • Results to support FDA 510(k) submission.
  • Long-term commercial supply agreement planned post-trial.
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.