CLEO Establishes U.S. Reimbursement Pathway

• CLEO to enter U.S. market under CPT code 81599 post-FDA clearance
• Reimbursement levels estimated at ~US$500-US$900 per test
• Strategy aims for long-term reimbursement and commercial scale

Cleo Diagnostics Ltd (ASX:COV) has outlined its U.S. reimbursement strategy for its Pre-Surgical Ovarian Cancer Test, set to launch immediately post-FDA clearance using the CPT code 81599. This code allows for early revenue generation and data collection, crucial for securing a dedicated CPT code. Reimbursement rates are estimated at $500-$900 per test, based on similar diagnostic tests. The company aims to apply for a dedicated CPT code after establishing clinical use and evidence, which will provide consistent reimbursement and broader adoption.