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How Cleo Diagnostics Secured FDA Backing for Its Ovarian Cancer Test
9:40am on Monday 15th of September, 2025 AEST
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Healthcare
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How Cleo Diagnostics Secured FDA Backing for Its Ovarian Cancer Test
9:40am on Monday 15th of September, 2025 AEST
Key Points
Positive FDA feedback at second pre-submission meeting
Clinical trial design and regulatory approach endorsed
Reduced regulatory risk ahead of 510(k) submission
Test targets early and accurate ovarian cancer diagnosis
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