A More Accurate Ovarian Cancer Test Will be Available

The Ovarian Cancer Research Foundation (OCRF) supported Hudson Institute of Medical Research to create a new ovarian cancer diagnostic test, which is now being commercialized by ASX-listed Australian business Cleo Diagnostics Ltd.

Cleo will expand the availability of its cancer diagnostics platform, which is intended to serve all ovarian cancer detection markets in the future with particular tests such as surgical triage, recurrence, high risk, and early-stage screening. The test will now enter a development phase before being validated for clinical usage.

A biomarker for ovarian cancer testing has been identified

CXCL10, a patented novel biomarker produced early and in high amounts by ovarian malignancies but not in non-malignant disease, will serve as the foundation for the blood tests. CXCL10 was discovered at Hudson Institute by Dr Andrew Stephens, Research Group Head of the Ovarian Cancer Biomarkers Research Group and currently Cleo’s Chief Scientific Officer.

The initial clinical application will concentrate on the surgical triage market in order to improve treatment outcomes for patients with ovarian cancer while avoiding unnecessary surgery and anguish for women with far more frequent non-cancerous illnesses. Beyond surgical triage, Cleo Diagnostics plans to perform more clinical trials to assess the efficacy of the underlying core technology for illness recurrence after surgery, with the eventual goal of developing broader screening applications in the general population.

There is no accurate and reliable ovarian cancer detection test – a pap test does not detect ovarian cancer. Ovarian cancer is the worst of all malignancies that affect women in Australia, and it is a silent killer. The current five-year survival rate is 49%, and it has not altered significantly in the last 50 years.

Ovarian tumors are frequently indistinguishable from non-cancerous illness. Currently, patients have a combination CA-125 blood test and ultrasound to assess their condition. However, neither is adequate for a correct diagnosis and is only utilized for surgical referral. The only approach to definitively confirm the existence of malignant illness is through invasive surgery to remove the ovaries.

As a result of the dearth of proper diagnosis equipment, a high number of women have a cancer scare, enduring unneeded worry, trauma, and invasive surgery.

Surgical triage examination

The CLEO Surgical Triage Test is being developed as a simple blood test that accurately differentiates benign from malignant disease without the need for surgical intervention.

The potential benefits are significant:

• Improved early evaluation of patients with the use of a simple blood test that delivers an actual cancer diagnostic assessment prior to surgery;
• High specificity and sensitivity in detecting cancer, allowing patients to be efficiently referred to a suitable gynaecological oncology surgeon for treatment.
• Patients with non-cancerous growths will benefit from more conservative treatment techniques; and
  Women who have a ‘cancer scare’ and must wait for a surgical diagnosis report a significant reduction in stress and anxiety.

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.”

The CLEO Triage Test, pending regulatory approval, has the potential to bring major advantages to the broader community, including:

Cost savings in the health care system (government, hospital, and health insurance); better care for women with non-cancerous tumors; more effective allocation of priority surgical beds; and community advantages linked with shorter hospital stays.

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.”

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