Cleo Secures 1,600 Samples and Positive FDA Feedback Ahead of 2026 U.S. Launch

Regulatory Progress with FDA

Cleo Diagnostics Ltd (ASX, COV) has reported encouraging progress in its quest to commercialize a simple blood test for early ovarian cancer detection. The company recently completed its second pre-submission meeting with the U.S. Food and Drug Administration (FDA), where it received detailed and positive feedback on key technical aspects such as clinical trial design, sample stability, and test specificity. This engagement reinforces confidence that Cleo’s pivotal clinical trial and regulatory strategy remain well aligned with FDA expectations, reducing regulatory risk ahead of a planned 510(k) submission next year.

Building a Robust Sample Library

To support its regulatory and product development efforts, Cleo has secured approximately 1,600 biobank samples from prestigious sources including the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), the Hudson Institute of Medical Research, and the Victorian Cancer Biobank Consortium. These samples cover a broad spectrum of ovarian cancer types and stages, including rare high-grade early-stage cancers, and come with rich clinical data such as ultrasound imaging, pathology reports, and genetic markers. This extensive internal resource is critical for refining Cleo’s pre-surgical test algorithm and accelerating the development of screening and recurrence tests.

Health Economics and Market Access Strategy

Recognizing the importance of economic validation for market adoption, Cleo has engaged specialist firms to conduct a health economic study quantifying the value of its ovarian cancer test within the U.S. healthcare system. Leveraging comprehensive reimbursement data and payer intelligence, this study aims to underpin payor engagement and reimbursement strategies. Additionally, Cleo is using detailed health system and claims databases to identify U.S. regions with the highest clinical need and commercial potential, positioning itself for a targeted and effective market launch following FDA approval.

Clinical Trial and Financial Position

Patient recruitment for Cleo’s pivotal U.S. clinical trial continues to progress well, with completion expected by the first quarter of 2026. Subsequent sample testing and analysis are scheduled within the same timeframe, contingent on commercial kit manufacturing. Financially, the company reported A$4.6 million in cash reserves at the end of September 2025, providing a runway to support ongoing development and regulatory activities.

Looking Ahead

Cleo Diagnostics is steadily advancing towards its goal of bringing a novel ovarian cancer blood test to the U.S. market in 2026. The combination of strong regulatory engagement, a substantial biobank sample base, and a focused market access strategy positions the company well to address a significant unmet clinical need. Investors and stakeholders will be watching closely as the company moves towards FDA submission and clinical trial completion in the coming months.