Cleo Diagnostics (ASX:COV) entered the analytical validation phase for its blood test for the early and accurate detection of ovarian cancer, according to a Monday Australian bourse filing.

The company completed the final development and preparation activities required for the phase, including commercial assay development as well as the completion of patient recruitment and prospective blood sample collection for its pivotal US clinical trial.

Analytical validation is expected to start in August upon receipt of the first manufactured batch of its test kits from Bio-Techne, per the filing. The company will evaluate three independently manufactured production batches to demonstrate assay reproducibility, manufacturing consistency, and overall analytical robustness.

The company said it expects analytical validation to take around four months to complete, adding that it anticipates US Food and Drug Administration submission to occur in the first half of 2027.

Cleo Diagnostics' shares fell nearly 6% in recent trading on Monday.