Cleo Completes Design Transfer

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to confirm that it has concluded design transfer activities relating to the core technology for its ovarian cancer detection test.

Highlights

• Design transfer establishes Cleo’s capability to deliver reproducible and reliable results for its ovarian cancer detection test
• Tender process for the selection of an antibody manufacturer in final stage
• Technology transfer to commence by end of the calendar quarter

Cleo has completed the design transfer of the CXCL10 active ratio test into a more rigorous laboratory environment, ensuring the capability to deliver reproducible and reliable results. This advancement enhances the performance of the test, transitioning it from academic methodologies to a compliant and robust laboratory setting. The test will continue to progress through the development pathway, culminating in an FDA 510K application for regulatory approval.

As outlined in the clinical validation study publication (see ASX Announcement 6 November 2023), the CXCL10 active ratio measures changes in a key immune process to give an indication of the presence of a tumour, and is an important component of Cleo’s biomarker panel to be incorporated within its commercially available test kits.

Cleo’s first product to market will be a pre-surgical triage test, designed to determine the likelihood that a pre-surgical ovarian mass is either benign or malignant prior to referral for surgical intervention. The test will be used in conjunction with clinical and radiological evaluation of a patient by physicians, to improve the referral process and better inform clinical decision making workflows. Ovarian masses (typically benign cysts) are very common and non-life threatening; around 10% of women will have surgery during their lifetime for investigation of an ovarian mass, representing a significant market opportunity for Cleo’s first product.

The completion of design transfer forms the basis for Cleo to progress technology transfer to a manufacturer as the next step. The Company is currently finalising a tender process for the selection of an antibody manufacturer and expects it will be in a position to announce a partner by the end of the quarter, with completion of technology transfer to follow shortly thereafter.

Commenting on the completion of design transfer, Cleo Chief Scientific Officer, Dr Andrew Stephens, said:

“The confirmation of design transfer demonstrates that the Cleo core antibody reagents and methodologies are robust and suitably reliable for transfer to a third party manufacturer for commercial test-kit development.”

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