CLEO Diagnostics Limited (ASX: COV) has announced a pivotal collaboration with Lindus Health to oversee the U.S. clinical trials of its innovative ovarian cancer blood test. This move marks a significant step towards gaining FDA approval. Chosen for its expertise in med-tech clinical trials, Lindus Health will manage the recruitment and study of up to 500 U.S. patients, aiming to validate the effectiveness of CLEO's test.
The study, set to commence next month, is a crucial component of CLEO's strategy to introduce its ovarian cancer detection technology to the U.S. market. Alongside, an Australian trial will run in parallel to ensure comprehensive data collection for FDA submission. CLEO's CEO, Richard Allman, highlighted the importance of this partnership in advancing their goal to enhance health outcomes for women facing ovarian cancer.
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