Cleo Diagnostics (ASX: COV) has optimised the biomarker panel underpinning its pre-surgical ovarian cancer blood test, expanding it from five to eight biomarkers to support commercial-scale deployment and regulatory progression.
The enhanced panel improves key requirements for regulatory approval and wider clinical adoption—namely analytical robustness, inter-assay reproducibility, and compatibility with manufacturing processes.
The inclusion of additional biomarkers reduces the test’s reliance on any single analyte and mitigates variabilities often observed in early-stage assay production, serving to significantly strengthen assay reproducibility and reduce technical risk.
Cleo’s original biomarker panel demonstrated strong diagnostic performance in distinguishing benign from malignant ovarian disease, establishing a solid foundation for its current development program.
Leveraging Ella Platform
The optimised biomarker panel leverages the capabilities of Cleo’s next-generation Ella automated enzyme-linked immunosorbent assay platform.
The platform contains microfluidic cartridge architecture that enables the simultaneous measurement of multiple biomarkers within a single sample, allowing expansion of the biomarker panel without compromising workflow efficiency, throughput, or sample utilisation.
The company’s novel patented CXCL10 biomarker remains central to the panel and continues to underpin its proprietary technology, with Cleo soon expected to lock in a binding agreement for kit manufacturing with its preferred manufacturing partner to support analytical validation activities.
Earlier this year, Cleo announced it had selected Ella to deliver its ovarian cancer technology to market.
Early Cancer Diagnosis
Cleo is developing a simple blood test for the accurate and early diagnosis of ovarian cancer based on the CXCL10 biomarker, which is produced early and at high levels by malignant ovarian cancers but is largely absent in benign forms of the disease.
The test aims to distinguish benign from malignant growths in a standard format that will be readily compatible with existing equipment used by diagnostic laboratories worldwide.
Chief executive officer Richard Allman said the company had achieved a critical milestone in transitioning the pre-surgical ovarian cancer test from research into a commercial-ready kit.
“This expanded biomarker panel improves assay robustness and reproducibility under real-world conditions, whilst maintaining strong clinical performance,” he said.
“Importantly, alignment with our manufacturing partner positions us for the imminent start of analytical validation which is the next key milestone towards our planned submission with the US Food and Drug Administration and entry into the US market.”
