Cleo Diagnostics (ASX:COV) has outlined the first stage of its United States commercialisation and reimbursement plan for its Pre‑Surgical Ovarian Cancer Test as it moves toward anticipated FDA clearance.
The company said it will launch in the US immediately after clearance, using the existing miscellaneous CPT code 81599, allowing case-by-case billing and the capture of real-world utilisation data that will underpin future reimbursement efforts.
The company explained that reimbursement for CPT code 81599 is negotiated payer by payer and is typically crosswalked to comparable multi-biomarker tests.
Cleo cited existing ovarian cancer assays, including OVA1, which have reported reimbursement levels of US$500 to US$900 per test, as a reference framework for initial pricing discussions. Using the miscellaneous code will enable early prescribing and clinical use across US healthcare settings while the company generates clinical and economic evidence.
Cleo said the short-term use of 81599 is the first step toward applying for a dedicated CPT code through the AMA CPT Editorial Panel once enough utilisation and supporting evidence have been assembled. A dedicated code is expected to improve reimbursement consistency and transparency, broaden payer coverage, and enable standardised utilisation tracking, thereby strengthening the long-term commercial value of the diagnostic platform.
To support market access and evidence generation, the company is advancing health economics work, onboarding key opinion leaders, and planning real-world evidence collection during the initial rollout.