A new blood test is now being developed to improve ovarian cancer diagnosis, with the potential to reduce unnecessary surgery leading to better health outcomes, saving time, stress and money for patients and the healthcare system.

Hudson Institute of Medical Research, funded by the Ovarian Cancer Research Foundation (OCRF), has developed a new diagnostic test for ovarian cancer, which is now being commercialised by ASX-bound Australian company Cleo Diagnostics Ltd.

Cleo will advance the availability of its cancer diagnostics platform, which is designed to eventually address all ovarian cancer detection markets with specific tests including surgical triage, recurrence, high risk, and early-stage screening. The test will now enter a development phase and undergo validation prior to clinical use.

Biomarker for ovarian cancer test identified

The blood tests will be underpinned by a patented novel biomarker, CXCL10, which is produced early and at high levels by ovarian cancers, but not in non-malignant disease. CXCL10 was first identified at Hudson Institute by Research Group Head of the Ovarian Cancer Biomarkers Research Group, Dr Andrew Stephens, who is also now Cleo’s Chief Scientific Officer.

Initial clinical use will focus on the surgical triage market to improve treatment outcomes for patients with ovarian cancer, and simultaneously avoid unnecessary surgery and anxiety for women with far more common non-cancerous conditions. Beyond surgical triage, Cleo Diagnostics will conduct further clinical trials to evaluate the effectiveness of the underlying core technology for disease recurrence following surgery and ultimately aims to develop broader screening applications in the general population.

Current ovarian cancer diagnosis and treatment

There is no accurate and reliable detection test for ovarian cancer — a pap test does not detect ovarian cancer. Ovarian cancer is the most lethal of all cancers affecting women in Australia, and a silent killer. The current five year survival rate is 49 per cent and this has not changed substantively in 50 years.

Ovarian cancers are often indistinguishable from common, non-cancerous disease. Currently patients undergo a combined CA-125 blood test and ultrasound to provide an assessment of disease. However, neither is sufficient for an accurate diagnosis and they are only used for surgical referral. Invasive surgery to remove the ovaries remains the only way to definitively diagnose the presence of malignant disease.

As a result, a large proportion of women experience a cancer scare, undergo unnecessary anxiety, trauma and invasive surgery due to the lack of accurate diagnostic technology.

Ovarian cancer surgical triage test

The CLEO Surgical Triage Test is being developed as an easy to administer blood test that accurately distinguishes benign from malignant disease without surgical intervention. The potential benefits are significant

• Improved early evaluation of patients using a simple blood test, that provides an actual cancer diagnostic assessment before surgery is considered;
• High specificity and sensitivity to identify cancer, allowing efficient referral of patients to an appropriate gynaecological oncology surgeon for treatment;
• Patients that are diagnosed with non-cancerous growths will benefit from more conservative management strategies; and
• Substantial reduction in stress and anxiety experienced by women who undergo a ‘cancer scare’ and must wait for a surgical diagnosis.

CLEO Diagnostics, Lead Medical Advisor, Professor Tom Jobling, commented, “There is often a delay in sending patients to a gynaecological oncology specialist for treatment, because defining whether a growth is likely to be malignant or not before surgery is very difficult. This new test will help ensure that an optimal management plan can be put in place early, which will streamline the referral process and provide the best care for patients. This also extends to patients with benign conditions, where early identification will permit direction to more appropriate use of resources.”

Pending regulatory approval, the CLEO Triage Test also has the potential to provide significant benefits to the broader community, including

• Cost savings in the health care system (government, hospital, health insurance);
• Improved care for women with non-cancerous tumours;
• More efficient allocation of priority surgical beds; and
• Community benefits associated with reduced hospital stays.

From lab bench to commercialisation

Hudson Institute’s CEO, Professor Elizabeth Hartland, said “Hudson Institute is delighted to be partnering with Cleo Diagnostics to take our work on ovarian cancer one step closer to delivering a much-needed diagnostic test. We thank the OCRF for being a long-term and dedicated supporter of this research.”

OCRF CEO Robin Penty added, “Through ongoing community support, the OCRF is proud to have nurtured this research from the lab bench through to the commercialisation phase. We are excited to see where Cleo takes it from here.”

Cleo Diagnostics recently closed a successful IPO to list on the Australian Securities Exchange (ASX). This funding will provide a runway over the next two years to enable an ovarian cancer blood test to be built, validated and made available for initial clinical triage use in 2025, with a staged execution strategy to other target markets until it is widely available.

Funder | Ovarian Cancer Research Foundation (OCRF)

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