MELBOURNE, AUSTRALIA, 15th September 2025: Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce that it has received positive feedback from the U.S. Food and Drug Administration (FDA) at its second pre-submission meeting for the Company’s first commercial product, being its Ovarian Cancer Pre-Surgical Triage Test.

Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce it has engaged and commenced work with EntityRisk and Norstella to deliver a United States (U.S.) focused health economic analysis and market assessment for its first commercial product, the Ovarian Cancer Pre-Surgical Test.

Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) is pleased to announce it has received formal approval from the U.S. National Cancer Institute (NCI) to access blood samples held within the globally respected Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial biobank. This represents a significant milestone that supports the Company’s planned FDA 510(k) submission for its Ovarian Cancer Pre-Surgical Test.