• CLEO selects Bio-Techne's Ella™ platform for its ovarian cancer blood test
• Ella™ platform can deliver improved assay sensitivity, precision and automation
• Binding agreement discussions with Bio-Techne for analytical validation and clinical trial completion

Cleo Diagnostics Limited (ASX:COV) is pleased to announce that it has selected Bio-Techne's Ella™ platform to deliver its ovarian cancer technology to market. The Ella™ platform is an automated enzyme-linked immunosorbent assay (ELISA) platform designed to deliver accurate, reproducible data with reduced manual input. Using CLEO's test kit, patient blood samples are processed in a laboratory on the Ella™ platform, which uses microfluidic cartridges to measure CLEO's proprietary biomarker panel. Key benefits of Ella™ compared to traditional ELISA include faster results, simultaneous analysis of multiple biomarkers, higher analytical sensitivity and precision, reduced manual input, and improved reproducibility and scalability. CLEO has been using Ella™ in-house since September last year and has confirmed the platform's capability to deliver its ovarian cancer technology. Both CLEO and Bio-Techne are well progressed in discussions to enter into a binding agreement to commence analytical validation (AV) of CLEO's test kits. Bio-Techne has already commenced preliminary development activities in the U.S., allowing for immediate commencement of work once formally engaged. The finished kits will then be used to test the ~500 blood samples collected as part of CLEO's pivotal clinical trial, with the results allowing for the completion of the clinical trial and forming the primary data package of its upcoming 510(k) FDA submission. Both parties are aligned to enter into a long-term commercial supply agreement following successful completion of these activities.

Both parties are aligned to enter into a long-term commercial supply agreement following successful completion of the analytical validation and clinical trial activities.