Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce the appointment of international Contract Research Organization (CRO), Lindus Health, as a key partner for its U.S. clinical trials program.
Highlights
CLEO has appointed U.S.-based Lindus Health to manage U.S. clinical trials for its revolutionary ovarian cancer blood testLindus Health is a leader in clinical trial management for the med-tech sector, with a strong record of timely and successful trial executionCLEO’s U.S. study will prospectively recruit up to 500 patients commencing next month and will verify the performance of CLEO’s pre-surgical ovarian cancer test for FDA regulatory approval.
As a part of CLEO’s U.S. market access program, the Company will partner with U.S.-based CRO, Lindus Health, appointing it to manage the successful execution of its ovarian cancer U.S. clinical trials. Lindus Health was chosen following a robust process to identify a partner with the proven experience, technology and high standards capable of delivering on CLEO’s objectives.
Lindus Health specialises in collaborating with med-tech companies to conduct clinical trials worldwide, leveraging their innovative patient recruitment and trial management technology platform to deliver efficient and timely outcomes.
Comprehensive U.S. patient data is essential for a successful regulatory application through the Food and Drug Administration (FDA). CLEO will leverage Lindus Health’s expertise to execute a cost-effective and rapid clinical study that will support its subsequent FDA 510(k) application.
The study will benchmark CLEO’s pre-surgical ovarian cancer triage test and provide the core data requirements for the FDA 510(k) application. Up to 500 U.S.-based patients will be recruited, with the trial scheduled over 10 months following ethic approvals and site engagement.
An Australian arm of the trial will also run concurrently and be managed directly by CLEO. This dual- arm strategy mitigates risk to the timelines due to patient recruitment, and will provide additional patient samples for kit verification following manufacture.
The study data will be published in the mainstream medical literature as a part of CLEO’s rigorous publication strategy.
Commenting on the partnership with Lindus Health, CLEO Chief Executive, Richard Allman, said:
“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.”
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