The Ovarian Cancer Research Foundation is very pleased to advise that research funded by the OCRF over twelve years has moved from the laboratory into the product development and commercialisation phase from August 22, 2023.
This first phase of commercialisation is focused on the production of an improved, accurate diagnostic test for ovarian cancer.
The new ovarian cancer surgical Triage Test was developed at the Hudson Institute of Medical Research, Melbourne by Professor Andrew Stephens and his team. It is being commercialised by Australian company Cleo Diagnostics Ltd to improve ovarian cancer diagnosis, with the potential to reduce unnecessary surgery, leading to better outcomes for patients and saving time and resources for the healthcare system.
With appropriate regulatory approvals, clinical application would commence in 2025.
Any commercialisation of new medical technology is a major step in translating work from the lab bench into clinical use. The OCRF is hopeful it is also a significant development in ovarian cancer diagnosis in Australia.
If successful, what will this test mean for women and patients with an abnormal ovarian growth?
Women and girls identified with an abnormal ovarian growth often face an anxious and uncertain wait, with current testing options insufficient to determine whether a lump is cancerous or not. Currently, as part of the clinical workflow, most patients will have a combination blood test for CA-125 and an ultrasound to screen for a mass in the pelvic area. Neither method is sufficient for an accurate diagnosis, and invasive surgery remains the only way to definitively identify the presence of malignant disease.
As a result, a large proportion of women who experience an ovarian cancer scare undergo unnecessary trauma and surgery due to the lack of accurate diagnostic technology.
The Cleo Triage Test is being developed as an easy-to-administer blood test that can distinguish benign from malignant disease accurately, prior to surgical intervention. The potential benefits on current diagnostic methods are:
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 cancers allowing efficient referral of patients to an appropriate gynecological oncology surgeon for treatment;
More conservative management strategies for patients that are diagnosed with non-cancerous growths; 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.”
AFTER VALIDATION, WHAT BENEFITS WILL THIS TEST OFFER TO THE HEALTH CARE SYSTEM AND BROADER COMMUNITY?
Improving the surgical referral process, through more accurate allocation of key health resources, may also lead to important economic benefits for the broader community, government and healthcare system.
Pending regulatory approval, the CLEO Triage Test could offer significant benefits to Australia more widely 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.
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.”
THE OVARIAN CANCER RESEARCH FOUNDATION’S SUPPORT FOR THIS RESEARCH
The Ovarian Cancer Research Foundation is proud to have nurtured this research into the commercialisation phase, and excited to see where Cleo takes it from here. Our aim continues to be provision of early and seed funding for research teams to achieve proof of concept through to clinical trial, and if successful, from there to commercialisation and development for clinical use.
This new technology was made possible through sustained, long-term funding provided by the OCRF over twelve years. This is thanks to the ongoing support of the OCRF’s dedicated and passionate community of supporters, corporate partners, fundraisers, survivors, friends and families who know that step-change in funding for medical research is the only answer.
NEXT STEPS FOR THE CLEO TRIAGE TEST FOR OVARIAN CANCER
Cleo Diagnostics had a successful IPO in July, and tomorrow (August 22), the company lists on the Australian Securities Exchange (ASX). Capital funds raised from the float will provide a runway over the next two years to enable assembly and validation of the blood test, and its transition to clinical use in 2025. Expanded testing in additional target markets will be accomplished according to a staged execution strategy, to ensure the test is made widely available at an affordable cost.
We look forward to reporting on further advancements from Cleo Diagnostics and this exciting step forward in ovarian cancer diagnosis. We will keep you up to date as progress continues.
FREQUENTLY ASKED QUESTIONS
What has been the process to commercialisation?
The Cleo Triage Test has been fifteen 15 years in the making. This step is the culmination of sustained funding provided by the OCRF and Hudson Institute, supporting the research team and evolution of this technology since 2008. This outcome is a demonstration of the time and ongoing commitment required to translate research from the lab bench to clinical application.
What is a listing on the Australian Stock Exchange?
The listing of Cleo Diagnostics is an important next step in securing the investment required to commercialise the build and validation of the Triage Test.
What form will the Test take?
The Triage Test is being developed as a simple blood test, using existing pathology infrastructure for ease of access and administration.
When will the Test be available?
Breakthroughs take time. Cleo Diagnostics aims to make the Test available for initial clinical triage use in 2025, with a staged execution strategy to other target markets until it is widely available over time.
Are we talking about early detection?
The CLEO Triage Test is underpinned by a novel biomarker that is over expressed in ovarian cancers (not expressed in benign disease) and remains throughout the lifetime of the cancer. This provides a robust indicator at all stages of cancer present. When considering current testing methodology, this Test will be fit for purpose as a cancer diagnostics test. However, further validation is still required, and appropriate regulatory approval processes must be followed. The Cleo Diagnostics team is also continuing to work on improving early detection methods by investing in different technologies.
Who can access the test?
GPs will continue to refer patients to specialists to diagnose ovarian cancer. In the initial stages of the roll out, the Test will be administered by specialists. Over time, we hope that the Test will be widely available for use by GPs.
What will it cost?
As a simple blood test, the Test will be priced appropriately so it is accessible. However, the final cost to the patient will be determined by other factors, including government subsidies.
GLOSSARY OF KEY TERMS
Biomarker:
A measurable change or presence of a molecule(s) that helps doctors and scientists understand if a certain disease is present.
Early detection:
Using methods such as biomarkers, early detection of cancer is diagnosing the disease before it’s had a chance to grow and spread (metastasize). Early detection of ovarian cancer increases the chances of successful treatment and recovery.
Commercialisation phase:
Transforming bench/lab-based research into practical products or services for clinical healthcare applications. This involves steps like securing intellectual property, developing products, obtaining regulatory approvals, collaboration with companies, clinical trials, market analysis and ongoing monitoring. This phase ensures innovative medical technologies and treatments reach patients and ultimately improves health outcomes.
Triage Test:
An initial pre-surgical test provided in a clinic that can determine the likelihood that a pre-surgical ovarian mass in a patient not yet referred to an oncologist (cancer specialist), is malignant.
High Specificity:
When a particular biomarker is good at correctly identifying patients that do not have the disease. A test that has high specificity is less likely to mistakenly label healthy individuals as having the disease.
Clinical Application:
The practical use of a method (such as a test or treatment) within medical and healthcare settings, to ultimately improve diagnosis, monitoring and treatment of diseases.