Cleo Diagnostics Hits Key U.S. Trial Milestone for Ovarian Cancer Test

CLEO Diagnostics Ltd ( (AU:COV) ) has shared an update.

Cleo Diagnostics has reached a pivotal milestone in its U.S. clinical development program, completing collection of 514 eligible blood samples and enrolling 624 women across 19 trial sites for its pre-surgical ovarian cancer test. The trial is designed to demonstrate the test’s performance against current tools in a diverse population of women scheduled for surgery due to adnexal masses.

With the sample collection target achieved, Cleo now moves into the final execution phase that will underpin its planned FDA 510(k) submission, including pre-verification, analytical validation on the Ella platform, clinical sample testing and statistical analysis of test performance. The company is also in the final stages of securing a binding manufacturing agreement for test kit production, a step that will set the timetable for the remaining validation work and marks progress toward commercialisation in the U.S. market.

The most recent analyst rating on (AU:COV) stock is a Buy with a A$1.26 price target. To see the full list of analyst forecasts on CLEO Diagnostics Ltd stock, see the AU:COV Stock Forecast page.

More about CLEO Diagnostics Ltd

Cleo Diagnostics Ltd is an ovarian cancer diagnostics company developing a pre-surgical blood test designed to assess the risk of ovarian malignancy in women with adnexal masses. The company is targeting the U.S. market, aiming to position its assay as an improvement over existing risk assessment tools used prior to surgery.

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