CLEO Advances Commercial Product Development with Completion of Alpha Testing

Highlights

• Completion of alpha testing using commercial prototypes of CLEO’s Ovarian Cancer pre-surgical triage assay kits
  
  
• Testing was conducted at CLEO’s laboratory and confirmed:
  – Robust and reproducible performance of all assay kit components;
  – Ability to differentiate Ovarian Cancer from benign disease;
  – Performance consistent with CLEO’s previously published in-house testing.
  
  
• CLEO now moves to next phase of development comprising assay optimisation, beta testing, and manufacturing scale-up in parallel to ongoing clinical trials to support FDA submission.

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MELBOURNE, AUSTRALIA, 12 May 2025: Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO or the Company) is pleased to announce the successful completion of alpha testing for its Ovarian Cancer pre-surgical triage test kit, marking a critical step along its manufacturing pathway towards commercial production.

Alpha Testing Completed

Alpha testing involved in-house testing of 120 blood samples using fully functional commercial prototypes provided by R&D Systems, a Food and Drug Administration (FDA) approved Contract Manufacturing Organisation (CMO). Testing confirmed a number of important outcomes that allow CLEO to progress its manufacturing activities, including:

• All components of the assay kits met design input specifications;
• Assays demonstrated robust and reproducible performance in multiple validation metrics
  across analytical precision, reproducibility, and measurement range;
• Most importantly, it confirmed differentiation of benign versus malignant ovarian disease,
  consistent with CLEO’s previously published studies¹.

Commenting on the achievement, CLEO's Chief Executive Officer, Dr Richard Allman, said:

"Completing alpha-testing is a pivotal achievement for CLEO. This validation of technical performance now clears the path to proceed towards scaled-up manufacturing. With strong partners and a clear roadmap, we are confident in our progress toward regulatory clearance and commercial launch."

Next Steps and Strategic Outlook

This successful completion of this milestone triggers the next phase of development comprising assay feasibility testing, optimisation, verification and manufacturing scale-up for commercial production.  These activities will be carried out in partnership with CLEO’s U.S. based development and manufacturing collaborator, R&D Systems, a subsidiary of Bio-Techne Corporation based in Minneapolis, USA.

CLEO’s structured development strategy ensures that the assay kits used in the Company’s ongoing U.S. clinical trials are materially identical to those intended for market release following FDA submission and approval, thereby improving the Company’s time to market.

Ovarian Cancer remains a significant unmet need, with over 300,000 new cases diagnosed each year and a 5-year survival rate of only 49%, making it the deadliest cancer to impact women globally.  CLEO’s pre-surgical test aims to improve diagnostic accuracy and clinical decision-making at the earliest possible point in patient care.

¹ 3.Stephens AN, Hobbs SJ, Kang S-W, Bilandzic M, Rainczuk A, Oehler MK, Jobling TW, Plebanski M, Allman R (2023). A Novel Predictive Multi-Marker Test for the Pre-Surgical Identification of Ovarian Cancer. Cancers doi: 10.3390/cancers 15215267

Link to ASX Release:  https://bit.ly/3S1NsZA

-ENDS-

For more information, Investors and Media can contact:

Dayna Louca
Head of Corporate Development
+61 409 581 972
[email protected]

Elvis Jurcevic
Investor Relations
+61 408 268 271
[email protected]