514 Blood Samples Collected as Cleo Advances Ovarian Cancer Test

Clinical Trial Milestone Achieved

Cleo Diagnostics Limited (ASX:COV) has announced a significant advancement in its development of a novel ovarian cancer diagnostic test. The company has completed the collection of 514 blood samples for its pivotal U.S. clinical trial, exceeding its initial recruitment target of 500 women. This milestone marks a critical step in the company’s journey towards regulatory approval and commercialisation of its Pre-Surgical Ovarian Cancer Test.

The trial enrolled a total of 624 women across 19 sites in the United States, focusing on patients with adnexal masses scheduled for surgery. Blood samples were collected prior to surgery and stored under controlled conditions, with pathology results obtained post-surgery to confirm diagnoses. The additional enrolments beyond the target reflect a prudent approach to ensure a robust dataset, accounting for patients who may not yield usable samples or confirmed pathology.

Manufacturing and Validation on the Horizon

Following recent optimisation of its biomarker panel, Cleo is in the final stages of negotiating a binding manufacturing agreement for test kit production. This agreement is pivotal as it will enable the company to proceed with formal clinical testing using the Ella™ platform, a key technology underpinning the assay.

The next phase involves several critical steps: pre-verification to confirm assay readiness, analytical validation to demonstrate consistent and reproducible performance, clinical sample testing to generate assay data, and comprehensive clinical data analysis to evaluate test accuracy metrics such as sensitivity and specificity. These activities will collectively form the clinical evidence package required for submission to the U.S. Food and Drug Administration (FDA) under the 510(k) pathway.

Implications for Ovarian Cancer Diagnosis

Ovarian cancer remains a challenging disease to diagnose early, often leading to poor patient outcomes. Cleo’s test, based on the patented biomarker CXCL10, aims to distinguish malignant from benign ovarian growths with a simple blood test compatible with existing laboratory equipment worldwide. Success in this trial and subsequent regulatory approval could represent a significant breakthrough, potentially improving early detection and surgical decision-making for women at risk.

Backed by over 15 years of research at the Hudson Institute of Medical Research, Cleo’s approach is designed to address a critical unmet need in women’s health. The company’s modular strategy also envisions expanding the test’s applications to recurrence monitoring, high-risk screening, and early-stage detection, broadening its impact across ovarian cancer care.

While the timeline for final validation and FDA submission depends on the manufacturing agreement’s execution, this milestone signals that Cleo is firmly on track to advance its innovative diagnostic solution through the regulatory pipeline.