Cleo Diagnostics (ASX:COV) said it plans to enter the US market immediately following anticipated Food and Drug Administration (FDA) clearance for its pre-surgical ovarian cancer test, enabling early billing and real-world utilization data capture, according to a Wednesday Australian bourse filing.

The company said reimbursement will be determined via cross-walking to comparable multi-biomarker tests, which have reported reimbursements of around $500 to $900 per test, supporting initial pricing discussions.

The approach represents the first step toward securing a dedicated CPT code to support long-term reimbursement and commercial scale, the filing added.

The company's shares rose 1% in recent Wednesday trade.