Cleo Diagnostics (ASX:COV) lists on the ASX today aiming to bring to market a simple blood test for the accurate and early diagnosis of ovarian cancer, based on the novel patented CXCL10 biomarker, which is produced early and at high levels by ovarian cancers but not in non-malignant disease. The test aims to distinguish benign from malignant growths in a standard format that will be readily compatible with existing equipment used by diagnostic laboratories worldwide.
The platform is backed by over 10 years of scientific Research & Development at the Hudson Institute of Medical Research, with two clinical studies conducted with over 500 patients. Pursuant to a licence agreement with the Hudson Institute of Medical Research, Cleo has a worldwide exclusive licence to commercialise the intellectual property which underpins its operations and the ovarian cancer tests.
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% 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.
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.
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 gynecological 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.
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.
The clinical unmet worldwide need is urgent. An accurate and early detection blood test could shift survivability for ovarian cancer significantly as seen with other cancers. Cleo is advancing the availability of its simple blood test, under a modular execution strategy which is designed to eventually address all ovarian cancer detection markets with specific tests including surgical triage, recurrence, high risk, and early-stage screening.
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