Cleo Diagnostics Advances Ovarian Cancer Test with FDA’s Positive Feedback
Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.
- Positive FDA feedback at second pre-submission meeting
- Clinical trial design and regulatory approach endorsed
- Reduced regulatory risk ahead of 510(k) submission
- Test targets early and accurate ovarian cancer diagnosis
- Progress towards U.S. commercial launch strengthened
FDA Feedback Marks Regulatory Milestone
Melbourne-based Cleo Diagnostics Ltd (ASX – COV) has taken a significant step forward in its quest to bring a novel ovarian cancer diagnostic test to the U.S. market. The company announced it received positive and detailed feedback from the U.S. Food and Drug Administration (FDA) during its second pre-submission meeting. This endorsement from the FDA validates Cleo’s clinical trial design and regulatory positioning, reducing uncertainty as it prepares for its 510(k) submission next year.
Clinical Trial Design and Regulatory Strategy Aligned
The meeting, held at the FDA headquarters in Silver Spring, Maryland, focused on key technical aspects including clinical trial design, sample stability, use of biobank samples, clinical specificity, and intended clinical workflow. The FDA’s positive guidance confirms that Cleo’s approach aligns well with regulatory expectations, enabling the company to refine its pivotal clinical trial protocols and data collection methods. This alignment is crucial for a smooth and expedited review process under the 510(k) pathway, which allows for faster approval by demonstrating substantial equivalence to existing devices.
Aiming to Transform Ovarian Cancer Diagnosis
Cleo’s test is designed to improve early and accurate detection of ovarian cancer through a simple blood test based on the patented CXCL10 biomarker. This biomarker is produced at high levels by ovarian cancers but is largely absent in benign conditions, offering a promising tool to distinguish malignant from non-malignant growths. Early diagnosis is critical in ovarian cancer, where survival rates improve significantly with timely intervention. Cleo’s test aims to support more appropriate surgical triage decisions, potentially improving patient outcomes.
Strategic Positioning Ahead of Commercial Launch
CEO Dr Richard Allman highlighted the importance of the FDA’s feedback, stating it provides confidence to proceed with the 510(k) submission strategy and underscores the clinical value of the test. The company’s ongoing engagement with U.S. regulatory bodies signals a clear pathway toward commercialisation in one of the world’s largest healthcare markets. Cleo’s modular strategy also envisions expanding its test portfolio to address recurrence monitoring, high-risk screening, and early-stage detection in the future.
Looking Ahead
While the FDA’s positive feedback is a promising development, the ultimate success of Cleo’s ovarian cancer test will depend on the outcomes of its pivotal clinical trials and the subsequent regulatory review. Investors and stakeholders will be watching closely as the company advances toward its 510(k) submission and eventual market launch.
Bottom Line?
Cleo’s strengthened FDA alignment sets the stage for a pivotal regulatory submission that could reshape ovarian cancer diagnostics.
Questions in the middle?
- When will Cleo submit its 510(k) application and what is the expected timeline for FDA approval?
- How will the clinical trial results impact the test’s commercial viability and adoption?
- What competitive advantages does Cleo’s CXCL10 biomarker test hold against existing ovarian cancer diagnostics?
