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.
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 studies*.
*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
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."