Cleo Diagnostics (ASX:COV) — Material Events
ASX:COV · 18 articles in the last 12 months · 100% assessed
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Major ≥90
Significant 75–89
Notable 50–74
Routine <50
Not assessed
Cleo Diagnostics Unveils 2 Million-Strong U.S. Market for Ovarian Cancer TestMedium
Cleo Diagnostics Expands U.S. Market Opportunity for Ovarian Cancer Test to 2 Million Women Annually
6 Nov 2025
·Market Update
·85
Cleo Diagnostics Hits Major Milestone in Ovarian Cancer Test TrialMedium
Cleo Diagnostics Completes Key Clinical Trial Milestone for Ovarian Cancer Test
31 Mar 2026
·Clinical Trial Update
·85
Cleo Diagnostics Advances Ovarian Cancer Test with Strong FDA BackingMedium
Cleo Diagnostics gains positive FDA feedback, advancing ovarian cancer test towards U.S. approval
15 Sept 2025
·Regulatory Update
·85
Cleo Diagnostics Completes Pivotal Trial Recruitment and Advances Manufacturing for FDA SubmissionMedium
Cleo Diagnostics completes pivotal trial recruitment, advances manufacturing and FDA submission preparations
29 Apr 2026
·Quarterly Activities Report
·85
Cleo Diagnostics Advances Ovarian Cancer Test with Key Trial and Biobank MilestonesMedium
Cleo Diagnostics advances ovarian cancer test with clinical trial progress, biobank access, and $6.46m cash
21 July 2025
·Quarterly Activities Report
·85
Cleo Diagnostics Boosts Ovarian Cancer Test Ahead of FDA PushMedium
Cleo Diagnostics expands biomarker panel and nears manufacturing deal ahead of FDA submission
23 Mar 2026
·ASX Announcement
·85
Cleo Diagnostics Expands U.S. Market and Nears FDA Submission MilestoneMedium
Cleo Diagnostics advances U.S. clinical trial, expands market, raises $5M, and progresses FDA pathway
29 Jan 2026
·Quarterly Activities Report
·85
Cleo Diagnostics Starts Manufacturing Program with Bio-Techne Ahead of FDA SubmissionMedium
Cleo Diagnostics Starts Manufacturing Program with Bio-Techne Ahead of FDA Submission
28 Apr 2026
·Regulatory and Manufacturing Update
·85
Cleo Diagnostics Advances Ovarian Cancer Test with FDA Backing and Clinical MomentumMedium
Cleo Diagnostics advances ovarian cancer test with positive FDA feedback and strong clinical progress
31 Oct 2025
·Quarterly Activities Report
·80
Cleo Diagnostics Secures $5M to Propel U.S. Ovarian Cancer Test LaunchMedium
Cleo Diagnostics raises A$5 million to fund U.S. launch and screening test development
18 Dec 2025
·Capital Raising
·80
Cleo Diagnostics Advances Ovarian Cancer Test with Bio-Techne’s Ella™ PlatformMedium
Cleo Diagnostics selects Bio-Techne's Ella™ platform for ovarian cancer test development
18 Feb 2026
·ASX Announcement
·80
Cleo Diagnostics Advances FDA Trial Amid Rising Losses and $9.4M Cash BoostMedium
Cleo Diagnostics reports increased loss, advances FDA trial and regulatory milestones for ovarian cancer test
25 Feb 2026
·Appendix 4D Half-Year Report
·75
Cleo Diagnostics Targets U.S. Market with Strategic Economic StudyMedium
Cleo Diagnostics launches U.S. health economic study to support ovarian cancer test market entry
18 Aug 2025
·ASX Announcement
·75
Cleo Diagnostics Advances to Analytical Validation Ahead of FDA SubmissionMedium
Cleo Diagnostics Commences Analytical Validation Phase Ahead of FDA Submission
13 July 2026
·Regulatory Update
·75
Cleo Diagnostics Sets U.S. Reimbursement Stage Ahead of FDA NodMedium
Cleo Diagnostics establishes U.S. reimbursement pathway for ovarian cancer test ahead of FDA clearance
20 May 2026
·Commercial Strategy Update
·75
Cleo Diagnostics Advances Ovarian Cancer Test Amid $4M LossMedium
Cleo Diagnostics advances ovarian cancer test development with FDA progress and $3.999M loss
26 Aug 2025
·Appendix 4E Preliminary Final Report
·70
Cleo Diagnostics Advances FDA Pathway with Key MDSAP MilestoneMedium
Cleo Diagnostics completes Stage 1 MDSAP audit, advancing FDA submission pathway
30 Oct 2025
·Regulatory Update
·70
Cleo Diagnostics Boosts Cash by $1.7M Ahead of US FDA MilestoneMedium
Cleo Diagnostics secures $1.7M R&D tax refund, boosts cash to $5.75M ahead of U.S. clinical trial and FDA submission
26 Nov 2025
·ASX Announcement
·65
No articles in this tier for the last 12 months.
Market Mentions
8
- appeared in market wrap coverage
These are market wrap articles where Cleo Diagnostics (ASX:COV) was mentioned. They reflect broader market coverage, not company-specific announcements.
Healthcare Wrap - Week 21 (18 May -> 22 May) 2026
23 May 2026
Healthcare Wrap - Week 18 (27 Apr -> 1 May) 2026
2 May 2026
Market Wrap - Week 14 (30 Mar -> 3 Apr) 2026
4 Apr 2026
Healthcare Wrap - Week 14 (30 Mar -> 3 Apr) 2026
4 Apr 2026
Healthcare Wrap - Week 13 (23 Mar -> 27 Mar) 2026
28 Mar 2026