• Updated U.S. insurance data identifies over ~2 million women per year could benefit from CLEO's test
• Findings reinforce the unmet need and significant commercial potential for CLEO's patented technology
• Data will inform a broader health economic study to support CLEO's market entry, reimbursement and early revenue generation

Cleo Diagnostics Limited (ASX:COV) has established a significantly larger Total Addressable Market (TAM) for the United States (U.S.) with respect to its Pre-Surgical Ovarian Cancer Test. The company commissioned Norstella, a market-leading global pharma intelligence solution provider, to reassess its initial pre-surgery patient market in the U.S. ahead of market entry next year. Analysis of the U.S. patient market based on open insurance claim data across commercial, Medicaid and Medicare channels identified ~3.4 million U.S. women each year with a suspected ovarian or adnexal mass, and an average ~2.0 million women per year proceeding to further diagnostic investigation. This ~2.0 million cohort aligns with current pre-surgical triage practice and defines the TAM and immediate commercial opportunity for CLEO's Pre-Surgical Ovarian Cancer Test. The findings indicate a materially larger and more accessible commercial opportunity than previously estimated, and the data also highlights geographical areas of high patient volume, allowing CLEO to strategically target and optimize its U.S. launch strategy. The information underpins a broader health economic study being conducted in partnership with EntityRisk and Norstella, which will quantify the clinical and economic value of CLEO's test in real-world healthcare settings. This work will be central to CLEO's U.S. reimbursement strategy, ensuring the company is positioned for successful market entry and adoption.

The findings indicate a materially larger and more accessible commercial opportunity than previously estimated for CLEO's Pre-Surgical Ovarian Cancer Test in the U.S. market.

CLEO's commercial strategy is built around a staged approach to ovarian cancer detection - beginning with pre-surgical triage and extending into recurrence monitoring, and ultimately early-stage screening. This deliberate pathway enables CLEO to progressively expand its addressable market and continue building value across all tiers of the ovarian cancer detection cycle, supporting long-term growth and leadership in women's health diagnostics.