Cleo Diagnostics Limited (ASX: COV), an ovarian cancer diagnostics company, has achieved significant milestones in its development program. They have finalized the selection of biomarkers for their ovarian cancer test-kit and developed a proprietary scoring algorithm. The test's performance was assessed in a clinical study of 334 patients, with results set for publication by the end of CY2023. Cleo is also preparing a patent application based on these findings. Additionally, Cleo is making progress in antibody development, demonstrating high-affinity binding in Surface Plasmon Resonance Analysis. They aim to control supply, quality, and cost of key reagents for test-kit manufacturing.
Hybridomas for producing supporting biomarker antibodies are advancing, with completion expected in Q2 CY2024. Cleo is actively evaluating four potential commercial antibody manufacturing partners through a robust tender process. Their goal is to ensure compliance with regulatory standards set by bodies like the FDA and potential customer groups. CEO Richard Allman emphasizes the rapid development of their ovarian cancer test-kit for the initial surgical triage market.
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