• Pivotal U.S. clinical trial sample collection completed, with >500 samples collected
• Bio-Techne's Ella™ platform selected as commercial immunoassay system
• Biomarker panel optimised to improve analytical robustness and manufacturability

Cleo Diagnostics Ltd (ASX:COV) has provided an update on its activities in the March 2026 quarter as it develops its simple and accurate blood test for the detection of ovarian cancer. The company achieved its recruitment target for its pivotal U.S. clinical trial, with 624 women recruited across 19 sites and 514 samples from eligible patients in storage. The next steps include pre-verification, analytical validation, clinical sample testing, and data analysis to generate the clinical evidence package required for FDA 510(k) submission. Cleo has selected Bio-Techne's Ella™ platform as the commercial immunoassay system to deliver its ovarian cancer test, citing benefits such as faster results, simultaneous analysis of multiple biomarkers, higher analytical sensitivity and precision, reduced manual input, and improved reproducibility and scalability. The company has also optimised its biomarker panel, expanding it from five to eight biomarkers to improve analytical robustness, inter-assay reproducibility, and manufacturing compatibility. Cleo has commenced its staged manufacturing program with Bio-Techne, focused on the development and optimisation of critical assay components, which will support analytical validation and regulatory submission.