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CLEO Diagnostics Ltd ( (AU:COV) ) has provided an announcement.
Cleo Diagnostics has completed sample collection for its pivotal U.S. clinical trial, surpassing its target with 624 women enrolled and 514 eligible samples stored for its planned FDA 510(k) submission. The company is now progressing through pre-verification, analytical validation, and clinical sample testing to generate the clinical evidence required for U.S. regulatory approval.
The company has selected Bio-Techne’s automated Ella platform as the commercial immunoassay system for its ovarian cancer blood test to support scalable, reproducible lab deployment. It has also expanded and optimised its biomarker panel from five to eight markers to improve analytical robustness and manufacturing readiness, and reports a cash balance of A$7.8 million, leaving it well funded to advance key clinical, regulatory, and commercial milestones.
The most recent analyst rating on (AU:COV) stock is a Buy with a A$1.26 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 is an ovarian cancer diagnostics company developing a simple blood test to distinguish benign from malignant disease. The ASX-listed firm focuses on pre-surgical detection using a proprietary biomarker panel, aiming to integrate its assay into existing laboratory workflows for scalable, global deployment.
Average Trading Volume: 243,112
Technical Sentiment Signal: Buy
Current Market Cap: A$93.07M
See more data about COV stock on TipRanks’ Stock Analysis page.