Cleo’s Regulatory Milestone: What Risks Lie Ahead Before FDA Approval?
Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.
- Stage 1 MDSAP audit completed successfully
- Positive regulatory feedback on quality management system
- Streamlined pathway for FDA submission and global market access
- Stage 2 audit scheduled for Q2 2026
- Supports commercial launch of Pre-Surgical Ovarian Cancer Test
A Crucial Regulatory Milestone
Cleo Diagnostics Limited (ASX, COV), a company focused on early ovarian cancer detection, has announced the successful completion of Stage 1 of the Medical Device Single Audit Program (MDSAP). This achievement represents a pivotal moment in the company’s regulatory journey, particularly as it prepares for FDA submission and broader global commercialisation.
The MDSAP is designed to harmonise regulatory audits across multiple jurisdictions, including the United States, Canada, Brazil, Japan, and Australia. By passing Stage 1, Cleo has demonstrated that its quality management system aligns with international standards, specifically ISO 13485, 2016, which governs medical device manufacturing and safety.
Streamlining Global Market Access
Completing this stage not only validates Cleo’s internal processes but also significantly streamlines its pathway to market. The single audit approach reduces duplication and accelerates regulatory approvals, a critical advantage for a company aiming to launch a novel blood test for ovarian cancer detection worldwide.
Positive feedback from auditors highlighted the clarity and regulatory alignment of Cleo’s quality system documentation, reinforcing confidence in the company’s readiness to meet stringent international requirements. This is particularly important given the complexity and urgency surrounding ovarian cancer diagnostics, where early and accurate detection can dramatically improve patient outcomes.
Looking Ahead to Stage 2 and FDA Submission
Stage 2 of the MDSAP audit, scheduled for the second quarter of 2026, will assess the full implementation and ongoing compliance of Cleo’s quality management system. Success in this next phase will be a critical enabler for the company’s FDA submission, a key regulatory hurdle for entering the lucrative U.S. market.
CEO Dr Richard Allman emphasised that completing Stage 1 strengthens the foundation for both regulatory approval and commercial strategy. The company’s innovative test, based on the patented CXCL10 biomarker, aims to distinguish malignant from benign ovarian growths through a simple blood test compatible with existing laboratory equipment.
With over a decade of research backing and clinical studies involving more than 500 patients, Cleo’s technology addresses a significant unmet need in women’s health. The company’s progress through the MDSAP reflects its commitment to quality, safety, and regulatory excellence as it moves closer to market launch.
Bottom Line?
Cleo’s MDSAP progress sets the stage for FDA submission, but the next audit will be the true test of readiness.
Questions in the middle?
- Will Stage 2 MDSAP audit proceed without delays or additional requirements?
- What is the anticipated timeline for FDA submission following Stage 2 completion?
- How will Cleo’s test pricing and reimbursement strategies evolve post-approval?
