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The latest update is out from CLEO Diagnostics Ltd ( (AU:COV) ).
Cleo Diagnostics Ltd has received positive feedback from the U.S. FDA during its second pre-submission meeting for its Ovarian Cancer Pre-Surgical Triage Test. This feedback supports CLEO’s clinical trial design and regulatory positioning, reinforcing alignment with FDA expectations and reducing regulatory risk ahead of its 510(k) submission. The guidance received allows CLEO to enhance its clinical trial design, strengthening data collection processes for a high-quality submission, and positions the company strongly for its upcoming U.S. commercial launch. This development marks a significant milestone in CLEO’s regulatory journey and underscores the potential impact of its test in providing a clinically meaningful solution for ovarian cancer surgical triage.
More about CLEO Diagnostics Ltd
Cleo Diagnostics Ltd is a company focused on the development of a simple blood test for the early and accurate diagnosis of ovarian cancer, utilizing the novel patented CXCL10 biomarker. This biomarker is produced early and at high levels by ovarian cancers but is largely absent in non-malignant disease. The test aims to distinguish benign from malignant growths and is designed to be compatible with existing diagnostic laboratory equipment worldwide. CLEO holds a worldwide exclusive license to commercialize the intellectual property from the Hudson Institute of Medical Research, where over 10 years of scientific R&D and clinical studies with over 500 patients have been conducted.
Average Trading Volume: 98,128
Technical Sentiment Signal: Buy
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