Cleo Diagnostics Advances FDA Approval Process

CLEO Diagnostics Ltd (AU:COV) has released an update.

Cleo Diagnostics Ltd has made significant strides in securing U.S. regulatory approval for its ovarian cancer detection test, with positive feedback and guidance from the FDA. The company’s clinical trial plans have received Institutional Review Board (IRB) approval in the U.S. and Australia, with patient recruitment and trial site contracting underway. This development is a crucial step for Cleo as it seeks expedited FDA approval through the 510(k) pathway for its pre-surgical triage test, aiming to improve early diagnosis and treatment outcomes for ovarian cancer patients.

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