Key points
- Cleo Diagnostics Ltd has received the first batch of commercial test kits from Bio-Techne
- Analytical Validation of the Pre-Surgical Ovarian Cancer Test is set to commence
- Three independently manufactured batches will be evaluated to demonstrate assay precision and consistency
Full summary
Cleo Diagnostics Ltd, an ovarian cancer diagnostics company, has announced the receipt of the first batch of commercially manufactured test kits, a significant milestone in the company's regulatory program. The first batch, consisting of 125 test kits, will undergo standard internal quality control and documentation procedures before Analytical Validation (AV) commences. AV is designed to demonstrate that the assay performs reliably and reproducibly from an analytical perspective, generating critical regulatory evidence required to support the Company's planned FDA 510(k) submission in H1 CY2027. The AV program will evaluate three independently manufactured production batches of commercial test kits to establish the analytical performance of Cleo's eight-biomarker assay and demonstrate consistent performance across separate manufacturing runs.
Outlook
Cleo Diagnostics Ltd is targeting completion of Analytical Validation by the end of CY2026, followed by Clinical Validation and FDA 510(k) submission in H1 CY2027.