Cleo Diagnostics Unveils 2 Million-Strong U.S. Market for Ovarian Cancer Test

Expanding the Market Horizon

Cleo Diagnostics Limited (ASX, COV), a Melbourne-based ovarian cancer diagnostics company, has announced a substantial expansion of its total addressable market (TAM) in the United States for its pre-surgical ovarian cancer test. Leveraging updated insurance claim data analyzed by Norstella, CLEO now estimates that approximately 2 million women annually undergo diagnostic procedures that align with the intended use of its test, a significant increase from previous market assessments.

This expanded TAM is drawn from a comprehensive dataset covering commercial, Medicaid, and Medicare insurance claims, providing a near real-time snapshot of healthcare utilization across the majority of the U.S. population. The data identified around 3.4 million women with suspected ovarian or adnexal masses annually, with roughly 2 million proceeding to further diagnostic investigations such as imaging or biomarker testing. This cohort represents the immediate commercial opportunity for CLEO’s patented CXCL10 biomarker-based test.

Clinical and Commercial Implications

CLEO’s test is designed to improve upon existing diagnostic tools like the CA125 blood test, offering superior accuracy in distinguishing malignant from benign ovarian masses. The company believes that as clinical adoption grows, the broader population of 3.4 million women with suspected masses could also benefit, potentially expanding the market further. This staged approach to market entry; starting with pre-surgical triage and eventually encompassing recurrence monitoring and early-stage screening; positions CLEO to progressively capture more segments of the ovarian cancer detection cycle.

Importantly, the new data also enables CLEO to strategically focus its U.S. launch efforts on geographic areas with high patient volumes, optimizing resource allocation and market penetration. While the current analysis does not yet quantify the subset of women proceeding to surgery, ongoing refinement is expected to provide a clearer picture of the active pre-surgical triage market.

Supporting Market Entry with Economic Evidence

To underpin its reimbursement strategy, CLEO is collaborating with EntityRisk and Norstella on a comprehensive health economic study. This research aims to quantify the clinical and economic value of the test in real-world healthcare settings, providing robust evidence to support discussions with U.S. payors and healthcare networks. Given the existing reimbursement landscape for similar diagnostic technologies, CLEO anticipates a materially larger and more accessible commercial opportunity than previously estimated.

CEO Dr Richard Allman highlighted the significance of these findings, noting the urgent unmet need in ovarian cancer diagnostics, which carries the highest mortality rate among female gynecological cancers. He emphasized that the expanded market data and forthcoming health economic modelling are critical to positioning CLEO for successful U.S. market entry and adoption.

Looking Ahead

With a patented technology backed by over 15 years of research and clinical studies involving more than 500 patients, CLEO is poised to make a meaningful impact in women’s health diagnostics. The company’s modular execution strategy aims to address multiple stages of ovarian cancer detection, potentially transforming survivability through earlier and more accurate diagnosis.