Just two months after it first floated on the ASX, ovarian cancer diagnostics company Cleo Diagnostics (ASX: COV). The ASX newcomer has delivered important early milestones in development of a precise and straightforward blood test for surgical triage. These milestones include finalising the biomarker panel and antibody development.

Cleo has finalised the selection of biomarkers to be used in its ovarian cancer test-kit and developed a proprietary scoring algorithm. A clinical study involving 334 patients has been conducted, and the results are being prepared for publication in a peer-reviewed medical journal by the end of 2023. Cleo is also preparing a new patent application based on the findings.

Tapping into the progress in antibody development, the Company is actively developing antibodies and target proteins to ensure control over supply, quality, cost, and performance of essential reagents for test-kit manufacturing. Surface Plasmon Resonance Analysis has confirmed the strong binding of core CXCL10 antibodies to their targets with high affinity, facilitating commercial assay development.

Cleo is nearing completion of its antibodies and monoclonal antibodies for each of the target biomarker points, crucial for the Triage Test (diagnostic test used in healthcare to quickly assess and prioritise patients based on the severity of their condition)’s success.

The development of the full test-kit panel, including progress on hybridomas for biomarker antibodies, is expected to be completed by Q2 CY24.

Cleo Chief Executive Officer Richard Allman commented, “The commercial foundation for our ovarian cancer test-kit targeting the initial surgical triage market is coming together quickly. We are running a number of initiatives in parallel which are designed to place the Company in a strong position to achieve key milestones set this financial year.”

Moving forward, Cleo is in the late stages of evaluating four commercial antibody manufacturing partners through a tender process. The evaluation assesses each partner’s capabilities to meet Cleo’s standards, aligning with FDA and customer requirements.

Another ongoing project is the development of their In Vitro Diagnostic (IVD) kit, which incorporates an algorithm to assess ovarian cancer risk. This kit will be tested using patient samples and will feature Enzyme-linked immunosorbent assays (ELISA) utilising Cleo antibodies. The performance of this IVD kit will be compared to that of commercially available kits.

Cleo is committed to conduct further performance evaluations, including scalability, patient, and clinician satisfaction, as part of its safety and compliance to gain regulatory approval in the US, Australia, and the EU. This will commence after antibody development and will run concurrently with IVD kit development.

The need for accurate and early ovarian cancer detection is urgent to improve survival rates. Cleo aims to address various ovarian cancer detection markets, including surgical triage, recurrence, high risk, and early-stage screening by developing a straightforward blood test for early and precise ovarian cancer diagnosis using the patented CXCL10 biomarker. Its primary objective is to differentiate between benign and malignant growths, compatible with existing diagnostic equipment. 

Backed by over a decade of research at the Hudson Institute of Medical Research, Cleo holds an exclusive licence to commercialise the technology. It has IP protection in place in the USA and Australia, with patents pending in Europe, China, India, Japan, Korea, Israel, New Zealand and Singapore. 

In its first full year report as an ASX-listed entity ending on 30 June 2023, Cleo reported $110k revenue, $1.7 million Net Loss After Tax (NLAT) and $239k cash at bank. There were no dividends paid, declared or recommended during the financial year.

Cleo was admitted to the official list of the ASX on 22 August 2023. Its IPO raised $12 million at an Offer Price of $0.20 per share.