Cleo Diagnostics (ASX:COV) started the technology transfer activities to develop its blood test designed for early detection of ovarian cancer, according to a Tuesday filing with the Australian bourse.
The technology transfer includes the transfer of its in-house development activities to a manufacturer to support commercial production, the filing said.
Accordingly, the company has partnered with US-based R&D Systems, a unit of Bio-Techne Group, to handle pre-production kit assembly and testing, the filing added.
After successful testing, a selected contract manufacturing organization (CMO) will expand production and complete verification and validation to produce in-vitro diagnostic kits for clinical use, the company said.
Final negotiations with US Food and Drug Administration-approved CMOs are underway, with the selection based on manufacturing capacity and regulatory compliance, the company added.
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