ASX:COV

2 stories mentioning ASX:COVUpdated 34d ago

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Cleo Diagnostics Outlines US Commercialization Strategy for Ovarian Cancer Test Ahead of FDA Clearance

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.

ASX:COV

Asia56d ago

Cleo Diagnostics Starts Manufacturing, Development Program for Ovarian Cancer Test Kit Production; Shares Up 8%

Cleo Diagnostics (ASX:COV) started a staged manufacturing and development program with life sciences firm Bio-Techne to support production of its ovarian cancer test kits, according to a Tuesday filing with the Australian bourse.The program will generate the test kits required for analytical validation and the evaluation of the clinical samples collected as part of the company's US study, the filing said.Data from analytical validation and clinical sample testing will form the core evidence package for the company's US Food and Drug Administration 510(k) submission, per the filing.Cleo Diagnostics shares rose 8% in midday trade on Tuesday.

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