Cleo Diagnostics Limited (ASX:COV) disclosed on 12 November 2026 that the U.S. laboratory infrastructure required for Clinical Validation of its Pre-Surgical Ovarian Cancer Test has been established at Asuragen, the CLIA-certified U.S. laboratory of Bio-Techne (NASDAQ: TECH), with testing anticipated to commence within the next month following receipt of test kits at the laboratory.

Key Points

  • Three Bio-Techne Ella™ automated immunoassay instruments installed and commissioned at Asuragen, establishing U.S. clinical testing infrastructure
  • Inter-laboratory reproducibility studies underway between CLEO's Melbourne facility and Asuragen
  • Clinical Validation program will involve approximately 1,470 samples across three study populations
  • Clinical Validation represents the final major clinical testing program supporting CLEO's planned FDA 510(k) submission in H1 CY2027

U.S. Laboratory Setup and Reproducibility Studies

Three of Bio-Techne's Ella™ automated immunoassay instruments have been installed and commissioned at Asuragen, establishing the laboratory infrastructure required to undertake clinical testing of CLEO's assay. Inter-laboratory reproducibility studies are now underway to demonstrate consistent assay performance between CLEO's Melbourne facility and Asuragen in the U.S., allowing direct comparison of results generated across both laboratories using the same manufacturing batch. The company said demonstrating reproducibility across laboratory environments is an important step in establishing readiness for clinical testing and supporting the reliability of the clinical data that will underpin its regulatory submission.

Clinical Validation Program Structure and Sample Populations

CLEO's Clinical Validation program will comprise three studies involving approximately 1,470 samples in total. The Pivotal Clinical Performance Study will involve approximately 600 prospectively collected blood samples from CLEO's pivotal U.S. clinical trial conducted across 19 sites, evaluating the test's ability to distinguish between benign and malignant ovarian disease in women presenting with a suspicious ovarian mass. The Clinical Specificity Study will evaluate approximately 570 samples from patients with non-ovarian benign and malignant conditions, while the Healthy Individuals Study will evaluate approximately 300 samples from healthy women to establish the expected distribution of test scores in a population without known disease.

Remaining Milestones Prior to FDA 510(k) Submission

According to the filing, the remaining major milestones prior to the company's planned FDA 510(k) submission include completion of Analytical Validation across three independently manufactured production batches, finalisation of the commercial assay algorithm, completion of Clinical Validation including pivotal clinical trial and control sample testing, clinical data analysis and trial results, and the FDA 510(k) submission itself. The resulting clinical dataset, together with results from CLEO's ongoing Analytical Validation program, will form the core evidence package supporting the planned FDA 510(k) submission in H1 CY2027.