Cleo Diagnostics Gains Access to PLCO Biobank to Strengthen FDA Submission

A Strategic Milestone in Ovarian Cancer Diagnostics

Cleo Diagnostics Limited (ASX, COV), an Australian company focused on early detection of ovarian cancer, has announced a significant advancement in its clinical development program. The company has secured formal approval from the U.S. National Cancer Institute (NCI) to access blood samples from the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial biobank. This biobank is widely regarded as a gold standard resource, containing rigorously collected and annotated biospecimens from over 155,000 participants followed longitudinally.

Access to the PLCO biobank represents a major endorsement of Cleo’s scientific approach and is expected to substantially strengthen the clinical evidence underpinning its FDA 510(k) submission for its Pre-Surgical Test. This test aims to accurately distinguish benign from malignant ovarian masses, a critical step in improving patient outcomes.

Driving Regulatory Confidence with Robust Data

Leveraging the PLCO samples, Cleo will initiate two pivotal studies, one focused on the Pre-Surgical market to validate test accuracy in a prospectively collected cohort, and another aimed at the Screening market to assess early detection capabilities in asymptomatic populations using longitudinal samples. These studies are designed to generate high-quality data that will not only support regulatory approval but also enhance clinical adoption and reimbursement prospects.

Importantly, the inclusion of U.S. population data addresses a common regulatory preference, potentially smoothing the FDA review process. Combined with Cleo’s existing partnership with University College London to access the UKCTOCS biobank, the company now benefits from complementary datasets representing diverse populations, further de-risking its regulatory pathway.

Clinical Trials and Commercial Strategy on Track

Meanwhile, Cleo’s pivotal U.S. clinical trials continue to recruit patients, with a strategic focus on diverse regional clinics and high-volume metropolitan surgical centers. The company anticipates completing recruitment by the fourth quarter of 2025, aligning with its timeline for FDA submission. Notable medical centers such as Beth Israel Deaconess, Yale, Duke, and Cleveland Clinic are among the sites joining the trial, underscoring the broad clinical support for Cleo’s technology.

CEO Dr Richard Allman highlighted the significance of these developments, emphasizing that access to the PLCO biobank and the complementary UKCTOCS resource will accelerate the company’s commercial strategy and help fast-track the development of its Screening Test. This modular approach aims to eventually address multiple ovarian cancer detection markets, including surgical triage, recurrence monitoring, and early-stage screening.

Looking Ahead, De-Risking and Market Potential

Cleo’s strategy to build a comprehensive clinical evidence package using internationally respected biobanks is a savvy move to mitigate regulatory risks and enhance market readiness. The company’s Pre-Surgical Test has already demonstrated impressive sensitivity and specificity in early studies, outperforming current standards of care. If these promising results are confirmed in the upcoming pivotal studies, Cleo could set a new benchmark in ovarian cancer diagnostics, a field with a critical unmet need for early and accurate detection.

As the company progresses toward FDA approval and eventual commercialization, investors and stakeholders will be watching closely for clinical trial outcomes and regulatory feedback. The integration of robust, real-world data from diverse populations positions Cleo well to meet these challenges.