Cleo Diagnostics (ASX:COV) has begun a staged manufacturing and development program with Bio-Techne to produce its ovarian cancer test kits, marking a significant step toward analytical validation and a planned FDA 510k submission.
The move follows completion of sample collection for CLEO’s pivotal US clinical trial, which recruited patients across 19 sites, and signals the company’s transition from trial enrollment into final assay development and clinical sample testing.
Under the agreement, CLEO will build on its existing work using Bio-Techne’s Ella platform, which the company has been using in-house and which has demonstrated the ability to deliver CLEO’s biomarker panel with high sensitivity, precision, and reproducibility.
The initial phase focuses on the development and optimisation of critical assay components, including antibody production and preparation for selected biomarkers from CLEO’s proprietary panel. These activities are intended to ensure assay consistency, reproducibility, and manufacturing readiness ahead of full-scale kit production.
Analytical validation is the next critical milestone and will generate the data required to demonstrate reliable and reproducible test performance prior to clinical sample analysis. CLEO says the staged approach is designed to reduce technical and manufacturing risk and to produce the test kits needed to support AV and subsequent testing of the clinical samples from its US study. Data from AV and clinical sample testing will form the core evidence package for the company’s FDA 510 (k) submission.
CLEO’s next actions include completion of reagent and antibody production, finalisation of assay components, manufacture of multiple production batches for use on the Ella platform, completion of AV, and testing of clinical trial samples using the validated test configuration, followed by analysis of clinical trial data to create the evidence package for regulatory review.
CLEO Chief Executive Officer Richard Allman said, “Commencing our manufacturing program with Bio Techne is an important milestone for CLEO as we transition from clinical sample collection into AV and sample testing.
"The staged approach allows us to optimise critical assay components and reduce technical and manufacturing risk ahead of full-scale kit production. Importantly it enables generation of the data required to support our planned FDA 510k submission.
"As a global leader in assay manufacturing, we have full confidence in Bio Techne’s ability to help deliver our project. With clinical sample collection completed and manufacturing activities now underway, CLEO is nearing the final execution phase of its U.S. clinical and regulatory program.”