Cleo Diagnostics Clears Key Regulatory Hurdle with Stage One MDSAP Audit Success

Cleo Diagnostics (ASX: COV) has reached a major regulatory milestone, announcing the successful completion of Stage One of the Medical Device Single Audit Program, or MDSAP. This marks a significant step toward global market access for its pre-surgical ovarian cancer diagnostic test.

The MDSAP allows medical device companies to meet the requirements of multiple major jurisdictions through a single, harmonised audit process. Jurisdictions covered include the United States Food and Drug Administration, Health Canada, the Therapeutic Goods Administration in Australia, and regulators in Japan and Brazil.

Cleo received positive feedback from auditors, who noted the clarity, completeness, and regulatory alignment of its quality management system. This quality system, certified under ISO 13485:2016, is a cornerstone of Cleo’s strategy to bring its patented diagnostic technology to global markets.

Stage Two of the MDSAP audit is scheduled for the second quarter of calendar year 2026. It will assess full implementation and ongoing compliance of the system. Successful completion of both stages is essential for Cleo’s planned submission to the FDA and subsequent commercial launch in key markets.

Chief Executive Officer Dr Richard Allman welcomed the result, stating: “Completion of Stage One of the MDSAP audit is an important reinforcement of the quality systems underpinning our technology and commercial strategy. It positions us strongly as we advance towards FDA submission and global commercialisation.”

Director of Quality and Regulatory Affairs Emma Lester echoed the sentiment, highlighting the company’s commitment to safety and compliance. “Participating in the MDSAP program reinforces Cleo’s commitment to quality, safety, and regulatory readiness. Successfully completing Stage One represents a significant achievement for the company and an important stepping stone toward our broader regulatory and commercial goals,” she said.

Cleo is developing a simple blood test for early and accurate detection of ovarian cancer, based on the patented CXCL10 biomarker. The test aims to distinguish benign from malignant growths and is designed to work seamlessly with existing diagnostic lab infrastructure.

Backed by more than a decade of research at the Hudson Institute of Medical Research and supported by clinical studies involving over 500 patients, Cleo holds the exclusive global licence to commercialise the underlying intellectual property.

With strong scientific foundations, regulatory momentum, and a modular development strategy aimed at multiple stages of ovarian cancer detection, Cleo is shaping up as a focused player tackling a critical unmet need in women's health.