Cleo Diagnostics to commercialise Australian-developed ovarian cancer diagnostic

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A new blood test is being developed in Australia that aims to improve the diagnosis of ovarian cancer.

Australian company Cleo Diagnostics is commercialising the new diagnostic test developed by the Hudson Institute of Medical Research with research funding provided by the Ovarian Cancer Research Foundation.

The test can potentially reduce unnecessary surgery leading to better health outcomes.

Cleo will advance the availability of its cancer diagnostics platform, 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 before clinical use.

The blood tests are underpinned by a patented novel biomarker, CXCL10, which is produced early and at high levels in ovarian cancers, but not in non-malignant disease. CXCL10 was first identified at Hudson Institute by Dr Andrew Stephens, 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.

Cleo Diagnostics will also conduct further clinical trials to evaluate the effectiveness of the underlying core technology for disease recurrence following surgery.

There is no accurate and reliable detection test for ovarian cancer. It is the most lethal of all cancers affecting women in Australia. The current five-year survival rate is 49 per cent. 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 the disease.

However, neither is sufficient for an accurate diagnosis and is only used for surgical referral. Invasive surgery to remove the ovaries remains the only way to diagnose the presence of malignant disease definitively.

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

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.

CLEO Diagnostics' lead medical advisor, Professor Tom Jobling, said, “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.”

Hudson Institute 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.”

Ovarian Cancer Research Foundation 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.”