Highlights
Commencement of U.S. Regulatory Process
CLEO 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 allow 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:
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.
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