Cleo Diagnostics meets test targets in trial

• Cleo Diagnostics achieved high diagnostic accuracy in its initial proof-of-concept trial across 247 individuals.
• Shares were unchanged at $0.30 following the release of the clinical results.
• Development now moves to bridging and expanded cohort studies ahead of evaluation in target populations.

Cleo Diagnostics (ASX:COV) met or exceeded all performance benchmarks in its first proof-of-concept study for a prototype ovarian cancer screening test.

The trial results exceeded minimum targets set for high-risk screening, achieving 92.2% sensitivity and 98.7% specificity against predefined thresholds of 90.0% for both measures.

The prototype test outperformed the current gold-standard CA125 test by delivering an area under the curve of 0.99 for Stage I detection.

The retrospective study evaluated 247 women, including 87 healthy individuals, 67 with benign conditions, and 93 with ovarian cancer.

The research programme is now progressing towards bridging and expanded cohort studies.

Following the announcement the Cleo Diagnostics share price was unchanged at $0.30.

The medical diagnostics company completed the first stage of its screening development programme following an earlier strategy announcement in September 2026.

Cleo Diagnostics is focused on expanding its proprietary ovarian cancer detection technology beyond pre-surgical triage into broader screening applications.