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CLEO Diagnostics Ltd ( (AU:COV) ) has shared an announcement.
Cleo Diagnostics has begun a staged manufacturing and development program with Bio-Techne to produce its ovarian cancer test kits, following the completion of sample collection for its pivotal U.S. clinical trial. The collaboration leverages Bio-Techne’s Ella platform and manufacturing capabilities to optimise assay components and prepare for larger-scale production.
This manufacturing phase will supply test kits for analytical validation and subsequent testing of clinical trial samples, generating the core data package for Cleo’s planned FDA 510(k) submission. By progressing reagent development, antibody preparation and assay optimisation in defined stages, the company aims to reduce technical and manufacturing risk and move into the final execution phase of its U.S. clinical and regulatory program.
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 listed on the ASX under the ticker COV. The company is developing a Pre-Surgical Ovarian Cancer Test that uses a proprietary biomarker panel, delivered on Bio-Techne’s Ella platform, to improve detection and risk assessment for patients in the U.S. and potentially other markets.
Average Trading Volume: 241,864
Technical Sentiment Signal: Buy
Current Market Cap: A$93.07M
For detailed information about COV stock, go to TipRanks’ Stock Analysis page.