Cleo Diagnostics Taps Prestigious U.S. Biobank to Strengthen FDA Submission for Ovarian Cancer Test

Key Highlights:

• Gains access to PLCO biobank—one of the most respected U.S. cancer datasets
• Two pivotal studies launched to support FDA 510(k) application and screening test development
• CEO Dr. Allman says milestone “significantly strengthens” regulatory and clinical pathway
• U.S. clinical trial remains on track for Q4 2025 completion
• COV shares up 8.82% to $0.37 during ASX trading hours

Cleo Diagnostics Ltd (ASX:COV) has secured access to one of the most respected cancer research resources in the United States—the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial biobank—marking a pivotal step in the company’s effort to bring its ovarian cancer diagnostic test to the U.S. market.

The Melbourne-based company announced today (Wednesday, June 25, 2025) that the U.S. National Cancer Institute (NCI) has granted Cleo formal approval to access PLCO’s rigorously curated blood samples, significantly strengthening its upcoming FDA 510(k) submission for the Pre-Surgical Test.

CEO Dr. Richard Allman welcomed the milestone, calling it “another strong endorsement of the scientific merit behind our technology.” He stated:

“The PLCO is a highly respected U.S.-based cancer screening study, and inclusion of data from this cohort will significantly strengthen the clinical evidence package supporting CLEO’s FDA 510(k) submission. Ultimately, this will help to fast-track our Screening Test development.”

$COV strengthens its planned FDA Submission following approval from U.S. National Cancer Institute (NCI) to access blood samples from the Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) Screening Trial.

CLEO will use samples from PLCO biobank to:
▪️Generate data to… pic.twitter.com/Occ5ck5EBb

— Cleodx (@Cleodiagnostics) June 25, 2025

Elevating Regulatory Strength and Global Credibility

Cleo will leverage PLCO samples in two pivotal studies:

Pre-Surgical Market: Assessing the test’s ability to differentiate malignant from benign adnexal masses.

Screening Market: Evaluating CLEO’s ability to detect cancer earlier using longitudinal data collected up to three years prior to diagnosis.

These studies follow previous trials where CLEO’s Pre-Surgical Test achieved 95% sensitivity and 95% specificity, outperforming current diagnostic tools.

Cleo’s FDA strategy is also reinforced by its recent partnership with the UKCTOCS biobank (UK Collaborative Trial of Ovarian Cancer Screening), giving it access to complementary datasets across U.S. and U.K. populations. Dr. Allman emphasized that this dual-biobank approach creates a globally representative evidence base:

“Together, these biobanks form a comprehensive, internationally representative intended-use population... substantially de-risking key regulatory milestones.”

Stock Snapshot (as of 1:57pm AEST, June 25, 2025):

• Price: $0.37
• Change: +8.82%
• Volume: 209,753
• Market Cap: $30.19 million
• 52-Week Range: $0.295 – $0.620

Strengthening U.S. Clinical Trial Pipeline

Cleo’s pivotal FDA-enabling trial in the U.S. is on track for Q4 2025 completion. The final phase of recruitment—targeting high-volume surgical centres—is set to begin July 2025, with expected participation from leading institutions including Yale University, Dana-Farber Cancer Institute, and Cleveland Clinic.

Crucially, using PLCO’s real-world data aligns with FDA preferences for U.S.-sourced clinical evidence, which is anticipated to:

• Improve regulatory confidence
• Enable efficient review timelines
• Support labelling claims
• Address FDA queries proactively

This alignment could fast-track Cleo’s pathway not just to FDA clearance, but also to commercial rollout and payer reimbursement.

The Bigger Picture in Cancer Diagnostics

Access to the PLCO biobank is highly competitive, and Cleo’s approval signals international scientific credibility. The PLCO study enrolled over 155,000 participants and spanned more than a decade—making it a “gold standard” resource in early cancer detection research.

Cleo’s flagship diagnostic platform, built on a patented CXCL10 biomarker, is designed to address the urgent global need for early ovarian cancer detection. With over 500 patients studied to date, the company is developing a modular testing suite aimed at surgical triage, recurrence, high-risk detection, and early-stage screening.

As geopolitical developments such as the Israel-Iran conflict and market volatility weigh on global equities, ASX investors have continued to back breakthrough health-tech plays. Still, companies with de-risked regulatory paths—like Cleo—remain attractive amid the noise.