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CLEO Diagnostics Ltd ( (AU:COV) ) has provided an update.
In an end‑of‑year letter to shareholders, Cleo Diagnostics outlined substantial progress in 2025 toward commercialising its blood‑based ovarian cancer test, highlighting advancement of its US pivotal clinical trial, a strengthened regulatory pathway toward FDA submission, and the build‑out of a staged commercialisation framework to support early market entry, clinical adoption and long‑term reimbursement. The company said it had expanded its total addressable market, deepened engagement with key opinion leaders, maintained disciplined capital management, and secured new institutional investors through a well‑supported capital raise, positioning it for a critical 2026 in which it plans to complete its US trial, seek FDA 510(k) clearance, begin commercial manufacturing and market launch, and accelerate development of a mass‑screening program aimed at addressing a significant global unmet need in ovarian cancer diagnosis.
The most recent analyst rating on (AU:COV) stock is a Buy with a A$1.15 price target. To see the full list of analyst forecasts on CLEO Diagnostics Ltd stock, see the AU:COV Stock Forecast page.
More about CLEO Diagnostics Ltd
Cleo Diagnostics Ltd (ASX:COV) is an Australian medical technology company focused on developing a simple blood test for the early and accurate detection of ovarian cancer, a disease with one of the highest five‑year mortality rates among women due largely to late diagnosis and the absence of effective screening tools. Its patented platform is built around the CXCL10 biomarker, which is produced early and at high levels in ovarian cancer but is largely absent in benign disease, enabling discrimination between malignant and non‑malignant growths. The company is pursuing a staged development and commercialisation strategy that begins with a pre‑surgical triage test and is intended to expand into recurrence monitoring and ultimately global screening, supported by an ongoing pivotal clinical trial and a planned US regulatory and commercial pathway.
Average Trading Volume: 255,151
Technical Sentiment Signal: Buy
Current Market Cap: A$80.95M
For detailed information about COV stock, go to TipRanks’ Stock Analysis page.