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How Cleo Diagnostics Secured FDA Backing for Its Ovarian Cancer Test

9:40am on Monday 15th of September, 2025 AEST 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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