• Expanded biomarker panel from 5 to 8 biomarkers to improve analytical robustness, reproducibility, and commercial manufacturability
• Optimised panel designed for high throughput Ella™ platform, supporting scalable global deployment without compromising performance
• Binding manufacturing agreement imminent with partner experienced in development and production of selected biomarkers

Cleo Diagnostics Limited (ASX:COV) has announced the optimisation of the biomarker panel underpinning its Pre-Surgical Ovarian Cancer Test, expanding from five to eight biomarkers to support commercial-scale deployment and regulatory progression. The optimised panel has been specifically designed to improve analytical robustness, inter-assay reproducibility, and compatibility with manufacturing processes - key requirements for regulatory approval and wider clinical adoption. CLEO's original biomarker panel demonstrated strong diagnostic performance in distinguishing benign from malignant ovarian disease, establishing a solid foundation for the Company's development program. Over the past six months, CLEO has undertaken expanded in-house assay development using the next-generation Ella™ immunoassay platform, which enables the simultaneous measurement of multiple biomarkers within a single sample, allowing expansion of the biomarker panel without compromising workflow efficiency, throughput or sample utilisation. The inclusion of additional biomarkers reduces reliance on any single analyte and mitigates variability often observed in early-stage assay production, significantly strengthening assay reproducibility and reducing technical risk ahead of analytical validation and regulatory submission. CLEO has also worked closely with its preferred manufacturing partner to align on the revised panel, with the partner bringing established expertise in the development and production of assays for these biomarkers, significantly reducing scale-up and manufacturing risk. A binding agreement for kit manufacturing to support analytical validation activities is expected imminently, with manufacturing of analytical validation lots anticipated to commence immediately following execution of this agreement, supporting CLEO's planned FDA 510(k) submission.

This represents a critical milestone in transitioning CLEO's Pre-Surgical Ovarian Cancer Test from research into a commercial-ready kit. The expanded biomarker panel improves assay robustness and reproducibility under real-world conditions, whilst maintaining strong clinical performance. Leveraging the capabilities of the Ella™ platform has allowed CLEO to enhance its panel without compromising workflow. Alignment with CLEO's manufacturing partner positions the company to commence analytical validation imminently - the next key milestone towards its planned FDA submission and entry into the U.S. market.