CLEO Selects CLIA Certified Laboratory for Pivotal U.S. Clinical Validation
Highlights
CLEO has engaged CLIA-certified U.S. laboratory, Asuragen, to assist in executing its pivotal Clinical Validation program for its Pre-Surgical Ovarian Cancer Test
The program will generate clinical performance data from over 1,300 samples to establish the sensitivity, specificity, PPV and NPV of CLEO’s test
Extends CLEO’s strategic relationship with Bio-Techne across commercial test kit manufacture, the Ella™ diagnostic platform and pivotal U.S. clinical testing.
10th September 2026: Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV (CLEO or the Company) is pleased to announce it has executed a Statement of Work (SOW) with Asuragen, the Clinical Laboratory Improvement Amendments (CLIA) certified U.S. clinical laboratory of Bio-Techne Corporation (NASDAQ: TECH), to conduct Clinical Validation (CV) for CLEO’s Pre-Surgical Ovarian Cancer Test.
The engagement further strengthens CLEO’s strategic relationship with Bio-Techne, integrating commercial test kit manufacture, the Ella™ diagnostic platform, and execution of the Company’s pivotal U.S. clinical testing program through Asuragen.
The appointment of Asuragen follows the recent receipt of the first production batch of test kits from Bio-Techne (refer to ASX announcement dated 3rd September 2026), which are progressing through internal verification ahead of formal commencement of Analytical Validation (AV).
Asuragen will conduct the clinical testing required to evaluate CLEO’s commercial test performance in the intended patient population and relevant control groups. The program will generate key clinical performance data, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
Clinical validation is a critical step in demonstrating that CLEO’s commercial assay performs reliably in its intended clinical setting. Together with the analytical performance data generated through AV, the results of the CV program will form the core evidence base supporting the Company’s planned FDA 510(k) submission targeted for 1H CY2027.
Pivotal Clinical Validation Program
The program comprises three principal studies:
Pivotal Clinical Performance Study: ~600 samples, collected through CLEO’s U.S. pivotal clinical trial across 19 sites, assessing the test’s ability to distinguish benign from malignant ovarian disease.
Clinical Specificity Study: ~570 samples from patients with non-ovarian benign or malignant conditions, to demonstrate the specificity of CLEO’s test.
Healthy Individuals Study: ~300 samples from healthy individuals to establish expected value ranges in a non-disease population.