• 514 blood samples collected for pivotal US clinical trial
• 624 women enrolled across 19 US sites
• Binding manufacturing agreement for test kit production in final stages

Cleo Diagnostics Limited (ASX:COV) has announced the completion of sample collection for its pivotal US clinical trial of its Pre-Surgical Ovarian Cancer Test. The trial was designed to demonstrate the performance of the company's test and benchmark it against existing tools used to assess the risk of ovarian malignancy. The trial recruited a minimum of 500 women, representing a diverse US population. Blood samples were collected prior to surgery and stored under controlled conditions, while pathology information was captured following surgery and diagnosis. The company has successfully recruited 624 women across 19 clinical trial sites, with 514 samples from eligible patients in storage. The natural lag between enrolment and collected samples reflects the standard clinical workflow. Consistent with standard clinical trial practice, recruitment continued beyond the 500-women target to ensure a sufficient number of usable samples for final analysis. Cleo is also in final discussions with a manufacturing partner to enter into a binding agreement for test kit production, following the recent completion of its biomarker panel optimisation. Next steps include pre-verification, analytical validation, clinical sample testing, and data analysis and validation to generate the clinical evidence package required for FDA 510(k) submission.

Cleo Diagnostics has not provided any high-importance, price-sensitive forward-looking financial metrics in this announcement.

Cleo Diagnostics is advancing the availability of its simple blood test for ovarian cancer detection under a modular execution strategy, which is designed to eventually address all ovarian cancer detection markets with specific tests including surgical triage, recurrence, high risk, and early-stage screening.