Cleo’s ovarian cancer blood test proves more effective than CA125 clinical benchmark and ultrasound

A benchmarking study comparing ovarian cancer diagnostics company Cleo Diagnostics (ASX: COV)’s blood test against ultrasound has been published in the scientific journal “Cancers” with positive outcomes. 

The study found that Cleo’s initial test for the surgical triage market significantly outperforms the current clinical workflows that use Cancer Antigen 125 (CA125) and ultrasound to predict ovarian cancer malignancy. 

Around 20% of ovarian cancers do not express CA125, and it is often in the “normal” range in patients with early-stage disease. False negative CA125 results (where cancers are “missed”) are fairly common. This ends up complicating the referral of cancer patients to a gynaecologic oncology specialist for primary surgery. 

According to the study, Cleo’s test correctly detected 90% of early-stage cancers, compared to only 50% using standard workflows, and it can be easily adopted for use in clinical practice. 

CLEO Chief Executive, Richard Allman, said, “Our peer-reviewed publication strategy is delivering gold-standard clinical evidence which is vitally important as we begin to engage with potential early adopters of our technology. 

“Having demonstrated now that the CLEO ovarian cancer blood test is far superior to CA125 and ultrasound in our initial pre-surgical triage market, we open up new dialogue with physicians to consider the potential material benefits that CLEO brings for their patients.

“More broadly, these encouraging results on early-stage cancer detection provide impetus for us to progress the development of CLEO’s screening test for ovarian cancer.”

Cleo aims to bring to market a simple blood test for the accurate and early diagnosis of ovarian cancer based on the novel patented CXCL10 biomarker. This biomarker is produced early and at high levels by ovarian cancers but is largely absent in non-malignant diseases. 

In Q3 FY24, Cleo spent about $657k on the triage test and reported $9.973 million cash at the bank on March 31, 2024. 

Ovarian cancers are only diagnosed after extensive and radical surgical intervention, and currently, up to 90% of suspected malignancies are post-surgically diagnosed as benign. Despite allegedly not being very effective, CA125 is exclusively recommended in medical guidelines and represents over $1 billion market. Its ubiquitous use has remained largely unchallenged since its introduction in the 1980s.

To address that, Cleo has focused on generating strong evidence to show doctors how its test can improve current clinical practice. The test has been developed in a format familiar to clinicians prescribing standard panel blood tests and will integrate seamlessly into current workflows. It is minimally invasive and economical and will utilise existing pathology lab infrastructure.

As part of its commercialisation program, the Company is focusing on several initiatives simultaneously that will deliver appropriate routes to the adoption of its tests following regulatory approval and market launch.