Ovarian cancer diagnostics company Cleo Diagnostics (ASX:COV) continues to make progress for its US clinical trials in support of its FDA application for its ovarian cancer diagnostic blood test.
CLEO is pursuing regulatory approval in the US as the largest diagnostics market in the world. Prior to submission with the Food and Drug Administration (FDA), the company will complete a study that will benchmark CLEO’s technology through a 500 patient clinical trial.
CLEO’s US-based clinical trials manager, Lindus Health, has now obtained Institutional Review Board (IRB) approval for, and formally contracted seven clinical trial sites across the U.S.
This follows CLEO obtaining IRB approval for its clinical trial design last month. A wide geographic range of sites ensures that a diverse representation of the US population is met. Initial sites that have been selected and contracted are located in Texas, Arizona, Florida (x2), Nevada, California, and New York. First patients are being recruited with the trials to begin mid-August 2024.
“This marks the first visible activity by CLEO in the US and effectively a large step in the journey there to bring our ovarian cancer diagnostic blood test to the largest diagnostic market in the world,” Chief Executive, Richard Allman, said.
“We believe that we have a sound strategy and plan that has been supported by the FDA and IRB, and we now move to progress our clinical trials that will ultimately drive our market entry.”
Australian Clinical Trials
CLEO has also announced that Human Research Ethics Committee Approval (HREC) has also been obtained for a similar trial design to be conducted in Australia. Whilst the US arm will provide the full complement of samples for CLEO's FDA application, any supplementary samples obtained locally will be used to further refine CLEO's technology and test algorithms prior to commercial launch.
