CLEO Commences Analytical Validation Ahead of FDA Submission

• Analytical Validation (AV) has commenced following receipt of the first batch of test kits
• Marks the start of formal regulatory testing of CLEO's assay
• AV will evaluate three independently manufactured batches to demonstrate assay precision and reproducibility

Cleo Diagnostics Ltd (ASX:COV) has announced the commencement of Analytical Validation (AV) of its Pre-Surgical Ovarian Cancer Test, marking the first formal regulatory study of the company's commercial assay ahead of its planned FDA 510(k) submission in H1 CY2027. The commencement of AV signifies Cleo's transition from assay development and optimization into formal validation testing under a prescriptive FDA framework. The program will establish the analytical performance of the test and generate the critical dataset required to support subsequent Clinical Validation (CV) and the company's FDA submission. AV is being conducted predominantly in-house using Bio-Techne's Ella automated immunoassay platform, with the resulting data forming an important component of the company's planned FDA 510(k) submission.

Cleo Diagnostics Ltd expects to complete Analytical Validation (AV) in approximately three months, following which Clinical Validation (CV) will commence, aiming for FDA submission and commercial launch next year.