Cleo Diagnostics Selects Next-Generation Ella Platform to Deliver Ovarian Cancer Blood Test

Core Insights - Cleo Diagnostics has selected the Ella automated ELISA platform from Bio-Techne Corporation to commercialize its ovarian cancer technology [1][3] - The Ella platform enhances assay sensitivity, precision, and automation while allowing simultaneous analysis of multiple biomarkers [2] Platform Capabilities - Cleo began using the Ella platform in September and confirmed its capability to support the ovarian cancer technology [3] - Advanced discussions are underway for a formal agreement for Bio-Techne to validate Cleo's test kits, which will be used to analyze approximately 500 blood samples in a pivotal clinical trial [3][4] Regulatory and Commercial Plans - The results from the clinical trial will form the primary data package for Cleo's upcoming 510(k) submission to the US FDA [4] - Cleo and Bio-Techne are preparing to enter a long-term commercial supply agreement following the completion of validation activities [4] Diagnostic Technology - Cleo is developing a blood test for early and accurate diagnosis of ovarian cancer based on the biomarker CXCL10, which is produced at high levels by ovarian cancers [5] - The test aims to differentiate between benign and malignant growths and is designed to be compatible with existing diagnostic laboratory equipment [5] Research and Efficacy - Cleo's technology is supported by over 15 years of research at the Hudson Institute of Medical Research, with two clinical studies involving more than 500 patients [6] - A benchmarking study in 2024 indicated that the test could detect 90% of early-stage cancers, significantly outperforming the 50% success rate of standard clinical workflows [6]