How Cleo Diagnostics Is Advancing Early Ovarian Cancer Detection in 2025
Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.
- U.S. clinical trial recruitment progressing, targeting Q4 2025 completion
- Alpha testing of diagnostic assay successfully completed
- Access granted to PLCO and UKCTOCS biobanks for pivotal studies
- Received A$845k R&D tax incentive for FY24
- A$6.46 million cash on hand as of June 30, 2025
Clinical Trial Progress and Recruitment
Cleo Diagnostics Ltd (ASX – COV) has provided a comprehensive update on its June 2025 quarter activities as it advances its blood test for early ovarian cancer detection. The company’s pivotal FDA-enabling clinical trial in the U.S. continues to recruit patients steadily, with a focus on diverse populations through regional clinics and now expanding to major metropolitan surgical centers. Recruitment sites such as the University of Florida and Cleveland Clinic are actively enrolling patients, with others like Yale and Duke University Medical Centres set to join shortly. This coordinated effort keeps Cleo on track to complete recruitment by the end of 2025.
Alpha Testing Milestone Achieved
During the quarter, Cleo completed alpha testing involving 120 blood samples using commercial prototypes manufactured by an FDA-approved partner. The testing validated key performance metrics including precision and reproducibility, aligning well with laboratory workflow requirements. This milestone is critical as the company moves toward scaling up manufacturing and preparing for commercial production of its first ovarian cancer diagnostic test.
Strategic Biobank Partnerships Bolster Regulatory Strategy
Cleo secured access to two of the world’s most prestigious biobanks – the U.S.-based PLCO biobank and the UKCTOCS biobank. These resources provide access to extensive, longitudinally collected biospecimens and clinical data, enabling two pivotal studies targeting pre-surgical and screening markets. Leveraging these biobanks enhances the robustness of clinical evidence supporting Cleo’s planned FDA 510(k) submission, expected in 2026. The studies will also help address regulatory questions proactively, improve confidence in test performance, and support future labeling claims.
Financial Position and Market Engagement
Financially, Cleo reported a healthy cash balance of A$6.46 million at quarter-end, supported by an $845,000 R&D tax incentive for FY24. The company continues to manage expenditures in line with its prospectus commitments, focusing on test development, antibody manufacturing, and general administration. Market activities included investor presentations and upcoming participation in biotech summits, reflecting ongoing efforts to engage shareholders and the broader investment community.
Looking Ahead
With clinical trial recruitment progressing and strategic partnerships in place, Cleo is positioning itself for a critical regulatory submission next year. The company’s focus on early detection of ovarian cancer addresses a significant unmet medical need, with the potential to improve survival outcomes dramatically. However, the path to FDA approval and commercialisation remains complex, requiring continued clinical validation and regulatory navigation.
Bottom Line?
Cleo’s upcoming FDA submission and trial completion will be pivotal in defining its commercial trajectory and impact on ovarian cancer diagnostics.
Questions in the middle?
- Will Cleo meet its Q4 2025 clinical trial recruitment completion target without delays?
- How will data from the PLCO and UKCTOCS biobanks influence FDA review and labeling claims?
- What are the company’s plans to extend testing beyond pre-surgical markets into broader screening?
