Cleo Diagnostics Completes Trial Recruitment and Advances FDA Submission Prep

Pivotal Trial Sample Collection Surpasses Target

Cleo Diagnostics has successfully completed recruitment for its pivotal U.S. clinical trial, enrolling 624 women across 19 sites and securing 514 eligible blood samples for its ovarian cancer blood test. This exceeds the 500-sample target needed to support the FDA 510(k) submission dataset, a critical regulatory milestone. The company continues recruitment beyond the target to ensure sufficient usable samples, acknowledging that not all enrolled patients yield pathology-confirmed samples suitable for analysis. This achievement builds on the momentum from the earlier sample collection milestone reported in March.

Ella™ Platform Selected for Scalable Commercial Deployment

In a strategic move to align its test with scalable laboratory infrastructure, Cleo has chosen Bio-Techne’s automated Ella™ platform as the immunoassay system for commercial rollout. The platform offers a 90-minute run time, multiplex biomarker analysis, and improved reproducibility compared to traditional ELISA methods. This selection supports the company’s goal to deliver a test compatible with existing diagnostic workflows, facilitating adoption post-approval. Cleo has been using Ella™ internally since September 2025 to accelerate assay development and expects this platform to underpin both analytical validation and clinical sample testing phases. This step complements the company’s earlier Ella™ platform integration announcement.

Expanded Biomarker Panel Enhances Test Robustness

The company has expanded its biomarker panel from five to eight markers, aiming to reduce reliance on single markers and improve assay stability and reproducibility. Central to the panel remains the proprietary CXCL10 biomarker, which has shown strong diagnostic performance distinguishing benign from malignant ovarian disease. This optimisation is designed to support manufacturing scalability and regulatory approval. The enhanced panel is being developed in close collaboration with Bio-Techne to ensure manufacturing readiness and aligns with the company’s planned FDA submission timeline. This follows the recent biomarker panel expansion reported in late March.

Manufacturing Program Commences to De-risk Production

Post-quarter, Cleo initiated a staged manufacturing program with Bio-Techne to produce clinical-grade test kits for upcoming analytical validation and clinical testing. This phased approach focuses initially on optimising critical assay components such as antibody production across the biomarker panel, laying the groundwork for consistent kit performance. The commencement of manufacturing activities materially reduces risks associated with scaling from development to commercial production. The company plans to complete analytical validation to demonstrate assay reproducibility before progressing to clinical sample testing, a core requirement for FDA submission. This development builds on the prior manufacturing program initiation disclosed in April.

Financial Position Supports Ongoing Milestones

As of 31 March 2026, Cleo held A$7.8 million in cash, providing a runway of approximately five quarters at current operating cash burn. The company’s expenditure during the quarter focused on research and development ($1.1 million), staff costs, and marketing activities aligned with ovarian cancer awareness initiatives. Payments to directors totalled $154,000. With this funding, Cleo is positioned to execute on key clinical, regulatory, and commercial milestones in the near term.

Urgent Need for Early Ovarian Cancer Diagnostics

Ovarian cancer remains the deadliest women’s cancer, with a five-year survival rate around 49%, starkly lower than breast cancer’s 92%. Early and accurate detection is critical to improving outcomes, yet no reliable non-invasive diagnostic test currently exists. Cleo’s blood test aims to fill this gap by distinguishing benign from malignant ovarian growths using a simple blood draw processed on an automated platform. The company’s progress in clinical validation and manufacturing brings it closer to potentially transforming diagnostic pathways for this unmet medical need.