Cleo Diagnostics (ASX:COV) initiates U.S. clinical trials for ovarian cancer blood test

Cleo Diagnostics Limited (ASX:COV) has officially commenced U.S. clinical trials for its ovarian cancer diagnostic blood test. The trials aim to validate the use of CLEO's ovarian cancer blood test for the U.S. market, with a pathway set toward FDA submission in CY2025. The pivotal FDA-enabling clinical trial has begun in the United States, with the first patients enrolled over 8 recruitment centers. The trial is designed to benchmark CLEO's technology, targeting a minimum of 500 patients with diversity representative of the U.S. population.

Executive Commentary on U.S. Clinical Trials Commencement

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.

Summary of U.S. Clinical Trials Commencement and Outlook

Cleo Diagnostics Limited (ASX:COV) has initiated U.S. clinical trials for its ovarian cancer diagnostic blood test, marking a significant milestone for the company. The trials aim to validate the use of CLEO's ovarian cancer blood test for the U.S. market, with a pathway set toward FDA submission in CY2025. The company's Chief Executive, Richard Allman, expressed confidence in the accuracy and early-stage cancer detection capabilities of CLEO's ovarian cancer blood test, highlighting its superiority over current clinical tools. With no existing diagnostic test for ovarian cancer, the opportunity for CLEO in the U.S. market is substantial. CLEO is well positioned and funded to achieve access into the initial pre-surgery test market, reflecting a positive outlook for the company's corporate strategy and goals.