• CLEO on track to meet FDA 510(k) submission target of H1 CY2027
• Staged test kit manufacturing program commenced with Bio-Techne
• Reimbursement pathway established; CLEO to enter U.S market using CPT code 81599
• Company well-funded with a cash balance of A$6.2m as at 30 June 2026

Cleo Diagnostics Ltd (ASX:COV) has made significant strides in its regulatory and commercial pathway towards FDA submission for its blood test for the detection of ovarian cancer. The company has entered the Analytical Validation phase following the completion of all preparatory milestones and has commenced a staged manufacturing program with Bio-Techne. Additionally, Cleo has established a reimbursement pathway in the U.S, enabling early billing and data capture post-FDA clearance. The company is well-funded with a cash balance of A$6.2 million as of June 30, 2026, positioning it to execute on key milestones.

FDA submission in H1 CY2027

Cleo Diagnostics Ltd is on track to meet its FDA 510(k) submission target in the first half of calendar year 2027, with analytical and clinical validation phases progressing as planned.