Cleo adds Royal Women’s Hospital to its clinical trial for ovarian cancer diagnosis

Cleo Diagnostics (ASX:COV) has expanded its clinical trials for a simple blood test to detect ovarian cancer, with the Royal Women’s Hospital in Melbourne joining as a participating site, and noted gynaecological oncology specialist Associate Professor Orla
McNally becoming principal investigator.

The addition of the hospital will offer a number of benefits to the trial: Not only expanding its cohort of patients to sample from, but boosting market awareness of the trial and of Cleo – given the Royal Women’s is Australia’s leading specialist hospital for women’s health.

Cleo is also progressing a U.S. clinical trial to facilitate its submission to the Food and Drug Administration (FDA) which is on-track for the 2025 calendar year. Patient recruitment is ongoing across eight sites; an expected 500 people will take part.

Royal Women’s Hospital Director of Oncology Associate Professor Orla McNally said the Australian trial would be a boon for diagnosis of ovarian cancer.

“Early and accurate detection of ovarian cancer is a critical unmet need,” she said.

“Cleo’s ovarian cancer blood test has the potential to better inform clinical workflows for clinicians to ultimately provide better health outcomes for women.

“We are pleased to be working with Cleo Diagnostics on this shared vision.”

Cleo has been trading at 35 cents.

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