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Cleo Diagnostics Begins Analytical Validation of Ovarian Cancer Test Kits
8:55am on Thursday 3rd of September, 2026 AEST
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Healthcare
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Cleo Diagnostics Begins Analytical Validation of Ovarian Cancer Test Kits
8:55am on Thursday 3rd of September, 2026 AEST
Key Points
First batch of commercial test kits received from Bio-Techne
Analytical Validation to assess assay performance across three batches
Validation data will support FDA 510(k) submission targeted for H1 2027
Clinical Validation preparations underway with pivotal U.S. trial samples
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