Cleo Diagnostics U.S. Clinical Trials Announcement

Cleo Diagnostics Limited (ASX: $COV) has appointed Lindus Health, an international Contract Research Organization (CRO), as a key partner for its U.S. clinical trials program. The U.S. clinical trials will focus on validating the performance of CLEO's pre-surgical ovarian cancer test for FDA regulatory approval, with the prospective recruitment of up to 500 patients commencing next month.

Executive Commentary on U.S. Clinical Trials Partnership

With the appointment of Lindus Health, our U.S. market access program is well underway to achieve our goal of obtaining regulatory approval for CLEO's initial pre-surgical market in the U.S. for our ovarian cancer blood test. CLEO is appointing high calibre partners that we believe will help us deliver our important ovarian cancer detection technology to improve the health outcomes for women.

Summary of Cleo Diagnostics U.S. Clinical Trials Announcement

Cleo Diagnostics (ASX: $COV) has partnered with Lindus Health to manage its U.S. clinical trials program for the validation of its pre-surgical ovarian cancer test. The appointment of Lindus Health, a leader in clinical trial management for the med-tech sector, signifies a significant step towards obtaining FDA regulatory approval. The U.S. study aims to prospectively recruit up to 500 patients and will provide essential data for the FDA 510(k) application. This strategic move reflects CLEO's commitment to advancing the availability of its simple blood test, which aims to significantly improve survivability for ovarian cancer patients.