Cleo Commences U.S. Clinical Trials

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to confirm the commencement of U.S. clinical trials for its ovarian cancer diagnostic blood test.

Highlights

• U.S. clinical trials commenced with first patients enrolled over 8 recruitment centres
• Trial will validate the use of CLEO’s ovarian cancer blood test for the U.S. market
• Pathway set toward FDA submission in CY2025.

Commencement of U.S. Clinical Trials

CLEO’s pivotal FDA-enabling clinical trial has commenced in the United States, with first patients recruited into the study. The trial is designed to benchmark CLEO’s technology, with recruitment targeting a minimum of 500 patients with diversity representative of the U.S. population. The data collected will underpin a submission to the Food and Drug Administration (FDA) seeking approval for clinical use of CLEO’s ovarian cancer detection blood test in the world’s largest diagnostic market.

Eight participating medical institutions, located across 6 U.S. states, are currently recruiting patients. Eligible patients at these sites will be identified by their primary physician and given the opportunity to participate during their consultation. Additional sites may also be included as the trial progresses.

Commenting on the commencement of U.S. clinical trials, CLEO Chief Executive, Richard Allman, said:

“Commencement of our U.S. trials confirm a significant milestone for CLEO and sets a clear pathway now for our planned entry into the U.S. market.

We have already demonstrated that CLEO’s ovarian cancer blood test is highly accurate, can detect early-stage cancer, and importantly is significantly better than clinical tools used today. This gives us confidence in moving through the trial activities to enable our FDA submission.

It is important to note that no diagnostic test exists today for ovarian cancer. Diagnosis can only be made after surgery. The opportunity in front of us is immense and CLEO is well positioned and funded to achieve access into our initial pre-surgery test market.”

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