Key Highlights

• Cleo Diagnostics has engaged Asuragen, the CLIA-certified laboratory of Bio-Techne Corporation, to conduct pivotal Clinical Validation for its Pre-Surgical Ovarian Cancer Test.

• The Clinical Validation programme will generate performance data from over 1,300 samples across three studies, establishing sensitivity, specificity, PPV and NPV for the commercial test.

• The engagement extends CLEO's relationship with Bio-Techne across test kit manufacture, the Ella™ diagnostic platform and now pivotal U.S. clinical testing.

• Clinical Validation data, combined with Analytical Validation results, will form the core evidence base for the company's planned FDA 510(k) submission targeted for 1H CY2027.

CLIA Laboratory Engaged for Pivotal Validation

Cleo Diagnostics Limited (ASX:COV) has announced the execution of a Statement of Work with Asuragen, the Clinical Laboratory Improvement Amendments (CLIA)-certified U.S. clinical laboratory of Bio-Techne Corporation (NASDAQ:TECH), to conduct Clinical Validation for CLEO's Pre-Surgical Ovarian Cancer Test. The engagement follows the recent receipt of the first production batch of commercial test kits from Bio-Techne, which are progressing through internal verification ahead of the formal commencement of Analytical Validation. The appointment of Asuragen integrates the clinical testing component of the validation programme into the broader Bio-Techne relationship, which also encompasses commercial test kit manufacture and the Ella™ diagnostic platform used for testing.

Clinical Validation Programme Structure

The Clinical Validation programme comprises three principal studies. The Pivotal Clinical Performance Study involves approximately 600 samples collected through CLEO's U.S. pivotal clinical trial across 19 sites and is designed to assess the test's ability to distinguish benign from malignant ovarian disease. The Clinical Specificity Study involves approximately 570 samples from patients with non-ovarian benign or malignant conditions, intended to demonstrate the specificity of the test against non-target disease states. The Healthy Individuals Study involves approximately 300 samples from healthy individuals to establish expected value ranges in a non-disease population. Together, the three studies will generate clinical performance data across more than 1,300 samples, producing measures of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the commercial assay.

Pathway to FDA Submission

Clinical Validation is described as a critical step in demonstrating that CLEO's commercial assay performs reliably in its intended clinical setting. The CV data, together with Analytical Validation results generated from the verification of the commercial test kits, will form the core evidence base for CLEO's planned FDA 510(k) submission, which is targeted for the first half of calendar year 2027. The 510(k) pathway requires a device to demonstrate substantial equivalence to a predicate device already legally marketed in the United States.

Technology Background: CXCL10 Biomarker

CLEO's test is based on the CXCL10 biomarker, which the company states is produced early and at high levels in ovarian cancer but is largely absent in benign ovarian disease. The company describes CXCL10 as a discriminator between malignant and non-malignant growths. The biomarker technology has been supported by more than 15 years of scientific research and development. Ovarian cancer carries the highest five-year mortality rate of all cancers affecting women, with 51% of patients dying within five years, primarily attributed to late diagnosis. The company is developing its test as a pre-surgical triage tool, with planned subsequent expansion into recurrence monitoring and ultimately broader screening applications.

Bio-Techne Strategic Relationship

CLEO's relationship with Bio-Techne spans multiple components of the commercial development pathway: Bio-Techne manufactures the commercial test kits, provides the Ella™ diagnostic platform on which the test is run, and now through Asuragen provides the CLIA-certified laboratory capacity for clinical testing. The integration of these components through a single strategic partner is intended to streamline the validation pathway and support the regulatory submission process. The company noted the first production batch of test kits received from Bio-Techne is currently progressing through internal verification.

Conclusion

Cleo Diagnostics (ASX:COV) has engaged Asuragen, Bio-Techne's CLIA-certified laboratory, to conduct pivotal Clinical Validation across more than 1,300 samples for its Pre-Surgical Ovarian Cancer Test. The programme will generate the sensitivity, specificity, PPV and NPV data required to support the company's planned FDA 510(k) submission targeted for 1H CY2027. The appointment consolidates the Bio-Techne relationship across kit manufacture, platform and clinical testing, representing a structured step toward the regulatory submission milestone.