Australian biotech Cleo Diagnostics (ASX:COV) has taken a step forward in its bid to bring an innovative ovarian cancer triage test to market, following positive guidance from the US Food and Drug Administration (FDA).
The company, which is developing a blood-based diagnostic to support more accurate pre-surgical triage for ovarian cancer, held its second pre-submission meeting with the FDA this month. Cleo’s Quality and Regulatory Manager, Emma Lester, attended the meeting in person at the agency’s headquarters in Silver Spring, Maryland.
The discussions focused on technical elements critical to the company’s US regulatory strategy, including clinical trial design, sample stability, use of biobank samples, clinical specificity, and intended use within surgical workflows. According to Cleo, the FDA’s feedback was “highly constructive” and reinforced confidence that its pivotal clinical trial design and broader regulatory approach are aligned with agency expectations.
By reducing regulatory risk and validating its 510(k) strategy, an expedited approval pathway for technologies that demonstrate equivalence to existing devices, Cleo said it is positioned to proceed with greater confidence as it prepares its submission next year.
Chief Executive Officer Dr Richard Allman described the outcome as a significant milestone. “This second round of positive feedback from the FDA marks another important milestone in our regulatory journey. The FDA’s guidance enables us to strengthen our trial design and move forward with greater confidence in our 510(k) strategy. It supports our approach and underscores the opportunity Cleo has to deliver a clinically meaningful and accessible solution to support more appropriate surgical triage for ovarian cancer,” he said.
Cleo’s platform is built around a patented biomarker, CXCL10, which is produced early and at high levels by ovarian cancers but largely absent in non-malignant disease. Backed by over a decade of research at the Hudson Institute of Medical Research, the company holds an exclusive worldwide licence to commercialise the test, which has already been validated in clinical studies involving more than 500 patients.
The company’s modular execution strategy aims to expand the test beyond surgical triage to other markets, including recurrence monitoring, high-risk populations, and eventually early-stage screening. Cleo says the clinical need is urgent: ovarian cancer remains one of the deadliest gynaecological malignancies, and earlier detection could significantly shift survivability.