• Following completion of commercial assay development, CLEO enters the formal pre-FDA submission validation phase
• Analytical validation expected to commence next month
• Three-batch validation design adopted to demonstrate assay reproducibility and manufacturing consistency
• Clinical validation preparations advanced, supporting efficient progression towards FDA 510(k) submission in CY2027

Cleo Diagnostics Ltd (ASX:COV) has completed the final development and preparation activities required to commence Analytical Validation (AV), marking the Company's transition into the formal phase of data collection ahead of FDA submission. This major milestone follows the successful completion of patient recruitment and prospective blood sample collection for the Company's pivotal U.S. clinical trial and the commencement of CLEO's kit manufacturing program with Bio-Techne. Testing is due to commence upon receipt of CLEO's first production batch of test kits expected from Bio-Techne next month, generating the first major analytical dataset supporting the Company's planned FDA 510(k) submission. AV is the first formal regulatory study performed using CLEO's commercial assay. As part of the study, CLEO will evaluate three independently manufactured production batches to demonstrate assay reproducibility, manufacturing consistency, and overall analytical robustness. Preparations for Clinical Validation (CV) are underway, including engagement of an external laboratory and finalisation of study protocols.

AV expected to take ~4 months to complete, FDA submission anticipated in H1 CY2027

CLEO anticipates FDA submission to occur in H1 CY2027, following completion of AV, CV, and other regulatory milestones.