Cleo Diagnostics Advances U.S. Market Strategy

Cleo Diagnostics Limited (ASX: COV) has initiated a strategic collaboration with EntityRisk and Norstella to strengthen its U.S. market entry for the Ovarian Cancer Pre-Surgical Test. EntityRisk will lead the health economic modelling to quantify the clinical and financial benefits of adopting the test, while Norstella’s subsidiary MMIT will provide reimbursement and payer intelligence to ensure evidence-driven insights. This partnership is designed to build a compelling reimbursement case, enabling early engagement with payors and supporting widespread adoption. Leveraging Norstella’s extensive claims and physician data, Cleo will refine its launch strategy by targeting regions with the highest clinical demand and commercial potential. Additionally, Norstella’s analysis will deliver a precise Total Addressable Market estimate, enhancing operational planning and investor confidence. With FDA submission and early revenues anticipated next year, this integrated approach positions Cleo to accelerate commercialisation, negotiate from a position of strength, and establish its innovative test in the complex U.S. healthcare landscape.

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