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CLEO Diagnostics Ltd ( (AU:COV) ) has shared an update.
Cleo Diagnostics reported strong progress in the December 2025 quarter as it advances towards U.S. commercialisation of its pre-surgical ovarian cancer blood test, highlighted by the appointment of its first U.S. key opinion leader, Dr Nicholas Lambrou, to drive clinical advocacy and early adoption, and new insurance data that significantly expands its immediate U.S. total addressable market to about 2 million women per year. The company’s pivotal U.S. clinical trial is on track to reach its initial 500-patient recruitment target in Q1 2026, it has completed Stage 1 of the MDSAP audit as part of its ISO 13485 and FDA submission pathway, is finalising a manufacturing partner ahead of commercial test kit production, and remains well funded with A$9.6 million in cash following a A$5 million placement and R&D tax refund, with growing broker research coverage signalling rising institutional interest.
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 diagnostics company focused on ovarian cancer, developing a simple and accurate blood test to detect the disease. The company is targeting the large U.S. pre-surgical market of women presenting with suspected ovarian or adnexal masses, positioning its test within existing triage pathways and aiming for regulatory clearance and reimbursement to support commercial rollout.
Average Trading Volume: 329,564
Technical Sentiment Signal: Buy
Current Market Cap: A$107.4M
See more insights into COV stock on TipRanks’ Stock Analysis page.