CLIA Certified Lab selected - Pivotal US Clinical Validation

Key points

• Cleo Diagnostics engaged CLIA-certified Asuragen for pivotal clinical validation
• Program will generate clinical performance data from over 1,300 samples
• Extends strategic relationship with Bio-Techne across multiple areas
• Results to support FDA 510(k) submission in 1H CY2027

Full summary

Cleo Diagnostics Limited (ASX:COV) announced the engagement of Asuragen, a CLIA-certified U.S. clinical laboratory, to conduct pivotal clinical validation for its Pre-Surgical Ovarian Cancer Test. The program will involve over 1,300 samples to establish key clinical performance metrics. This engagement strengthens Cleo's strategic relationship with Bio-Techne, integrating commercial test kit manufacture, the Ella diagnostic platform, and clinical testing. The clinical validation is crucial for demonstrating reliable performance in the intended clinical setting, forming the core evidence base for the planned FDA 510(k) submission targeted for the first half of calendar year 2027.