CLEO Screening Test Meets Rigorous Performance Targets

• Prototype screening test met and exceeded performance targets
• Achieved 92.2% sensitivity and 98.7% specificity for high-risk screening
• Outperformed gold-standard CA125 with AUC of 0.99 for Stage I cancers

Cleo Diagnostics Ltd announced that its prototype ovarian cancer screening test has successfully met and exceeded pre-defined performance targets in its first proof-of-concept study, marking an important milestone in its screening development program. The study, which involved 247 individuals, including 62 cases of early-stage ovarian cancer, demonstrated that the prototype achieved 92.2% sensitivity and 98.7% specificity for high-risk screening, and 75.0% sensitivity and 100.0% specificity for general population screening. The test also outperformed the current gold-standard biomarker CA125, with an AUC of 0.99 for Stage I cancers and 0.98 for all-stage cancers. These results support the potential of Cleo Diagnostics' technology to address the significant unmet need for early detection of ovarian cancer.