Study shows Cleo Diagnostics’ ovarian cancer blood test outperforms current clinical benchmark

A benchmarking study comparing Cleo Diagnostics’ (ASX: COV) novel blood test for the accurate and early detection of ovarian cancer against conventional ultrasound options has been published in the scientific journal Cancers.

The study compared the blood test with current standard clinical workflows that use cancer antigen 125 (CA125) testing and ultrasound to predict malignancy.

The outcomes build on previous results from March, demonstrating the blood test to be “far superior” to routine clinical tools used by doctors to predict the diagnosis of a lump in the tissue near the ovaries or fallopian tubes (known as an adnexal mass) before surgery.

Importantly, the benchmarking study showed that Cleo’s test could correctly detect 90% of early-stage cancers compared to the 50% success rate of CA125 and ultrasound.

Clinical evidence

Cleo chief executive officer Richard Allman said the benchmarking study had delivered “gold standard clinical evidence” for the company.

“This evidence is vitally important as we begin to engage with potential early adopters of our technology,” he said.

“We can now open up new dialogue with physicians to consider the potential material benefits that Cleo might bring to their patients.”

He added that the results would help progress the development of the company’s screening test for ovarian cancer.

Commercial pathway

Mr Allman stated that the study results supported the company’s planned commercial pathway.

“We are focusing on a number of initiatives that will deliver appropriate routes to the adoption of these tests following regulatory approval and market launch,” he explained.

“The publication strategy provides a strategic foundation for clinical implementation and uptake and critically supports our case for reimbursement of the blood test to enable early revenue.”

Surgical intervention

Under current practice, ovarian cancers are diagnosed only after extensive and radical surgical intervention, with up to 90% of suspected malignancies being post-surgically diagnosed as benign.

Less than 50% of ovarian cancer patients receive a primary referral to an oncology surgeon, which can delay and sometimes compromise their treatment.

Mr Allman described this as a “major failing” in the pre-surgical clinical evaluation process, impacting patient treatment outcomes and the allocation of healthcare resources.

CA125 entrenched

Despite its reportedly poor clinical performance, CA125 is exclusively recommended for ovarian cancer diagnosis in medical guidelines.

It represents an annual addressable market of over $1 billion and its use is believed to have remained largely unchallenged since its introduction in the 1980s.

Mr Allman said Cleo is focused on changing standard practice by generating strong evidence to show doctors how its blood test can provide important and material improvements for patients.

The test has been developed in a format familiar to clinicians prescribing standard panel blood tests and is expected to integrate seamlessly into current workflows.

It is minimally invasive and economical and is designed to utilise existing pathology lab infrastructure.