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CLEO Diagnostics Ltd ( (AU:COV) ) has issued an announcement.
Cleo Diagnostics Ltd has successfully completed Stage 1 of the Medical Device Single Audit Program (MDSAP), marking a significant milestone in its global regulatory strategy. This achievement enhances Cleo’s pathway to FDA submission and commercial launch of its Pre-Surgical Ovarian Cancer Test, with Stage 2 scheduled for Q2 CY2026. The MDSAP audit allows medical device companies to meet regulatory requirements across multiple major jurisdictions through a single audit process, streamlining global market access. The positive feedback received on Cleo’s quality management system reinforces its commitment to quality, safety, and regulatory readiness, positioning the company strongly for future commercialization efforts.
More about CLEO Diagnostics Ltd
Cleo Diagnostics Ltd is a company focused on developing a simple blood test for the early and accurate diagnosis of ovarian cancer using 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 company aims to provide a test that can distinguish between benign and malignant growths, compatible with existing diagnostic laboratory equipment worldwide. Cleo Diagnostics holds a worldwide exclusive license to commercialize the intellectual property supporting its operations and ovarian cancer tests, based on over 10 years of research and development at the Hudson Institute of Medical Research.
Average Trading Volume: 168,343
Technical Sentiment Signal: Strong Buy
Current Market Cap: A$48.83M
See more data about COV stock on TipRanks’ Stock Analysis page.