• Initial phase of staged manufacturing program now underway with Bio-Techne
• Follows completion of sample collection for CLEO's pivotal U.S. clinical trial
• Staged approach designed to reduce technical and manufacturing risk

Cleo Diagnostics Limited (ASX:COV) has commenced a staged manufacturing and development program with Bio-Techne Corporation (Bio-Techne) to support production of its ovarian cancer test kits, marking a key milestone towards analytical validation (AV) and FDA submission. This follows CLEO's recent milestone achievement of completing sample collection for its pivotal U.S. clinical trial, with patients recruited across 19 clinical trial sites. The Company has now transitioned into the final execution phase of its clinical and regulatory program, with commencement of manufacturing and assay development activities supporting progression through AV and subsequent clinical sample testing. Bio-Techne, a leading global life sciences company, has been selected as CLEO's preferred partner due to its extensive expertise in immunoassay development and commercial-scale manufacturing. The staged manufacturing and development program will focus on the development and optimisation of critical assay components, including antibody production and preparation across selected biomarkers within CLEO's proprietary biomarker panel. This approach is designed to reduce technical and manufacturing risk ahead of full-scale kit production. The data generated from AV and clinical sample testing will form the core evidence package for the Company's planned FDA 510(k) submission.

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