CLEO (ASX:COV) has appointed Lindus Health, a US-based company, to manage US clinical trials for its ovarian cancer blood test.
CLEO is developing a simple blood test for the accurate and early diagnosis of ovarian cancer based on the novel patented CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but is largely absent in nonmalignant disease.
Lindus Health is a leader in clinical trial management for the medical technology sector. CLEO said the US study will prospectively recruit up to 500 patients commencing next month. It aims to verify the performance of CLEO's pre-surgical ovarian cancer test for FDA regulatory approval.
An Australian arm of the trial will run concurrently and be managed directly by CLEO. The company said the dual arm strategy mitigates risk to the timelines due to patient recruitment and will provide additional patient samples for kit verification following manufacture.
CLEO CEO Richard Allman said, “With the appointment of Lindus Health, our US market access program is well underway to achieve our goal of obtaining regulatory approval for CLEO’s initial pre-surgical market in the US 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.”