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Cleo Commences U.S. Regulatory Process with FDA

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce progress in its regulatory strategy for its first commercial product, the pre-surgical triage test.


  • Initial pre-submission meeting held with the U.S. Food & Drug Administration (FDA) where CLEO outlined its submission framework and clinical plan
  • Positive feedback from FDA provides confidence in CLEO’s U.S. regulatory strategy
  • Clinical trial design receives Institutional Review Board (IRB) approval in both U.S. and Australia

Commencement of U.S. Regulatory Process

CLEO has completed an initial pre-submission meeting with the U.S. Food and Drug Administration (FDA) where the Company outlined its submission framework and clinical plan for its ovarian cancer detection blood test. The pre-submission meeting is designed to permit CLEO to receive early guidance from FDA review teams prior to an eventual application submission.

The meeting was interactive with the FDA providing constructive and positive feedback on CLEO’s approach to obtaining regulatory approval in the U.S. for its ovarian cancer detection blood test. This outcome provides confidence that CLEO’s clinical trial designs and strategic direction are appropriately aligned with FDA requirements.

Early interaction with the FDA is important as a part of CLEO’s U.S. market access strategy for a number of reasons, as the guidance outcomes allow CLEO to:

  • Refine its clinical trial design to maximise resourcing and quality of data;
  • Reduce the possibility of rework;
  • Shorten the potential timeframe to application submission; and
  • Operate with an open and transparent approach.

CLEO is pursuing expedited FDA approval for its first ovarian cancer detection product – the pre-surgical Triage test – via the 510(k) application pathway. This approach provides the quickest pathway to achieve regulatory approval for devices that achieve ‘substantial equivalence’ to an existing predicate.

Clinical Trial Activity

CLEO’s clinical trial design has now been reviewed and approved in both the U.S. and Australia. Institutional Review Board (IRB) approval is a legal requirement for any clinical trial, to ensure trial activities are ethically sound and compliant with federal regulations.

Trial sites are being formally contracted, and patient recruitment is to commence shortly. CLEO is working with U.S.-based Contract Research Organization (CRO), Lindus Health to manage the international arm of the trial.

Click here for the full ASX Release

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