CLEO Delivers Commercial Development Milestone
Highlights
CLEO has commenced technology transfer marking the completion of a critical milestone towards the commercial production of its first Ovarian Cancer diagnostic test
Development will be carried out by global leader in immunoassay technology, R&D Systems, Inc. a subsidiary of Bio-Techne Corporation based in Minneapolis, USA
Final negotiations are underway with selected FDA-registered CMO’s ahead of transition to large-scale manufacturing
Milestone achievement represents significant progression along CLEO’s strategic pathway towards FDA submission.
MELBOURNE, AUSTRALIA, 18 March 2025: Ovarian Cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to announce the commencement of technology transfer activities supporting the development of its simple blood test for the early and accurate detection of Ovarian Cancer. This marks the completion of a critical milestone in the manufacturing pathway for CLEO to deliver its commercially available, FDA-compliant diagnostic test kit.
TECHNOLOGY TRANSFER
After successfully completing design transfer, CLEO has commenced the next phase of its strategic development with the commencement of technology transfer. This process involves the transfer of its in-house development activities, including hybridoma cell line development, antibody production and testing, and selection and finalisation of reagents, to a manufacturer to facilitate commercial production.
To assist with this, CLEO has engaged U.S.-based R&D Systems, Inc., a global leader in immunoassay technology and a subsidiary of the Bio-Techne Group, to scale-up and assemble CLEO's proprietary antibodies for use in CLEO’s initial Ovarian Cancer test targeted at the surgical triage market. With state-of-the-art production facilities and globally recognised expertise, the partnership with R&D Systems, Inc. ensures the successful progression of commercial prototype development and supports CLEO's transition to large-scale manufacturing. R&D Systems, Inc. will undertake the remaining steps towards pre-production kit assembly and testing.
Following successful testing, CLEO's selected CMO will assist in scaling production capability, in addition to verification and validation activities, ensuring the production of GMP and ISO13485 compliant in-vitro diagnostic (IVD) kits for clinical deployment. These test kits will support the completion of CLEO's ongoing clinical trials in the U.S. and Australia, which will enable CLEO to submit its 510(k) application to the FDA.
Negotiations with key FDA-approved CMOs are in their final stages, with the ultimate decision to be based upon manufacturing capability, regulatory compliance and ability to scale to production to meet demand upon product launch.
Commenting on the milestone achievement, CLEO's Chief Executive Officer, Dr Richard Allman, said:
"The commencement of technology transfer marks a pivotal milestone in CLEO's strategic pathway toward commercialisation. During this phase, we refine and scale our assay technology, to ensure the Company is well positioned to progress its Ovarian Cancer test from prototype production to a commercially available, FDA-compliant diagnostic kit.
More broadly, this step is also integral to our strategy of delivering a highly accurate, accessible cancer diagnostic solution that addresses a critical and global unmet need in population screening for Ovarian Cancer detection."