Highlights

  • Cleo Diagnostics shares surged 7.48% to AUD 0.58 on 31 March 2026, marking a 64.29% increase over the past year.
  • The Company successfully completed sample collection for its pivotal U.S. clinical trial, reaching its target with 514 blood samples.
  • Recruitment exceeded expectations with 624 women enrolled across 19 clinical sites in the United States.
  • The milestone clears the path for the final execution phase leading to an FDA 510(k) submission.
  • Binding manufacturing agreements for test kit production are in the final stages following biomarker panel optimisation.

Cleo Diagnostics Limited (ASX:COV) shares advanced 7.48% to AUD 0.58 during the afternoon session on 31 March 2026. Today’s price appreciation follows the company's announcement of a major regulatory breakthrough: the completion of the sample collection phase for its pivotal U.S. clinical trial.

The stock continues to demonstrate significant market momentum, having climbed 64.29% over the last twelve months as investors react to the rapid de-risking of its ovarian cancer diagnostic technology.

U.S. Clinical Trial Achievement and FDA Pathway

Cleo has officially reached its recruitment and sample collection targets for the clinical study designed to validate its Pre-Surgical Ovarian Cancer Test. The trial is a critical component of the Company’s regulatory strategy, providing the primary clinical evidence required for an FDA 510(k) submission.

Key metrics from the trial include:

  • Enrolment Success: 624 women were enrolled across 19 specialized sites in the U.S., ensuring a diverse and robust dataset.
  • Sample Target Met: 514 blood samples have been collected and placed in controlled storage, surpassing the minimum requirement of 500.
  • Benchmarking: The study compares Cleo’s diagnostic performance against current existing tools used to evaluate the risk of malignancy in women with adnexal masses.

By recruiting beyond the initial 500-woman target, Cleo has implemented a strategic buffer to ensure the final dataset remains statistically significant even after standard clinical exclusions or pathology finalisation.

Transition to Final Execution Phase

With the samples secured, Cleo is moving into the high-activity "Final Execution" phase. This workflow is designed to convert raw clinical samples into a validated data package for regulators. The upcoming steps include:

  1. Pre-verification: Internal testing to ensure the assay and kit components perform to specification.
  2. Analytical Validation: Formally demonstrating the reproducibility of the test on the Ella™ platform.
  3. Clinical Sample Testing: Generating actual results from the 514 collected U.S. samples using the final optimized test kit.
  4. Data Analysis: Statistical validation of sensitivity, specificity, and Predictive Values (NPV/PPV) against confirmed surgical pathology.

Manufacturing and Commercial Readiness

The Company also confirmed that it is in the final stages of securing a binding agreement with a manufacturing partner for the production of its test kits. This follows the successful optimisation of the biomarker panel (CXCL10) announced on 23 March 2026.

The execution of this manufacturing contract is the final prerequisite before formal clinical testing begins. The biomarker technology, which stems from 15 years of R&D at the Hudson Institute of Medical Research, is designed to be compatible with standard diagnostic laboratory equipment worldwide, facilitating rapid global adoption once approved.

Investor Takeaway

Cleo Diagnostics (ASX:COV) has successfully transitioned from a recruitment-focused phase to a data-generation phase, significantly reducing the "execution risk" associated with clinical trials. The 64.29% share price growth over the past year reflects the market's growing confidence in Cleo’s ability to hit its stated milestones.

With the sample collection now complete, the focus shifts to the clinical data results. If the final analysis confirms the high sensitivity and specificity seen in previous studies, Cleo will be positioned to enter the massive U.S. surgical triage market with an FDA-cleared product, addressing a substantial unmet need in early ovarian cancer detection.