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Cleo Moves Ovarian Cancer Test Into FDA Validation Pathway
8:50am on Tuesday 13th of October, 2026 AEDT
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Medical Technology
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Cleo Moves Ovarian Cancer Test Into FDA Validation Pathway
8:50am on Tuesday 13th of October, 2026 AEDT
Key Points
Analytical Validation has commenced after receipt of the first 125 Bio-Techne production kits
Three independently manufactured batches will be assessed for precision, reproducibility and robustness
Testing is being conducted predominantly in-house on Bio-Techne’s Ella platform
Clinical Validation and final algorithm work remain ahead of the planned FDA 510(k) submission
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