U.S. lab infrastructure established ahead of Clinical Validation
Cleo Diagnostics (ASX:COV) has established the U.S. laboratory infrastructure required for Clinical Validation (CV) of its Pre-Surgical Ovarian Cancer Test. CV testing is anticipated to commence within the next month, following receipt of test kits at the laboratory.
Testing will be carried out with Asuragen, the CLIA-certified U.S. laboratory of Bio-Techne (NASDAQ: TECH), as referred to in the ASX Announcement dated 10 September 2026.
CV is the final major clinical testing program in CLEO’s regulatory pathway. It will establish the clinical performance of the company’s commercial assay in its intended-use population, and it supports the planned FDA 510(k) submission in H1 CY2027.
Instruments installed and reproducibility studies underway
Demonstrating that a test performs the same way in different laboratories supports the reliability of the clinical data that will underpin CLEO’s regulatory submission. The company said this is an important step in establishing readiness for clinical testing.
Three of Bio-Techne’s Ella™ automated immunoassay instruments have recently been installed and commissioned at Asuragen. This establishes the laboratory infrastructure required to undertake clinical testing of CLEO’s assay.
Inter-laboratory reproducibility studies are now underway between CLEO’s Melbourne facility and Asuragen in the U.S. They allow direct comparison of results generated across both laboratories using the same manufacturing batch.
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Inside the ~1,470-sample Clinical Validation program
Two measures matter most when regulators assess a diagnostic test. Sensitivity is how well a test identifies people who have a disease, while specificity is how well it correctly identifies people who do not. The CV studies will generate clinical performance data, including both measures, within the test’s intended clinical application.
CLEO’s CV program will comprise three studies involving approximately ~1,470 samples.
The pivotal trial enrolment behind these samples ran well above the minimum target, with 624 women recruited and a surplus of usable blood draws beyond the 500-sample threshold.
| Study | Approx. samples | Sample source | Purpose |
|---|---|---|---|
| Pivotal Clinical Performance Study | ~600 | Prospectively collected blood samples from CLEO’s pivotal U.S. clinical trial conducted across 19 sites | Evaluates the test’s ability to distinguish between benign and malignant ovarian disease in women presenting with a suspicious ovarian mass |
| Clinical Specificity Study | ~570 | Samples from patients with non-ovarian benign and malignant conditions | Assesses potential confounding factors that may influence test results and informs appropriate product labelling |
| Healthy Individuals Study | ~300 | Samples from healthy women | Establishes the expected distribution of test scores in a population without known disease |
The resulting clinical dataset, together with results from CLEO’s ongoing Analytical Validation (AV) program, will form the core evidence package supporting the company’s planned FDA 510(k) submission.
What happens next for CLEO on the road to FDA submission
With AV now underway and CV set to commence shortly, CLEO’s remaining major milestones prior to FDA submission are:
- Completion of Analytical Validation, including testing across three independently manufactured production batches
- Finalisation of commercial assay algorithm
- Completion of Clinical Validation, including pivotal clinical trial and control sample testing
- Clinical data analysis and trial results
- FDA 510(k) submission
Two of these carry stated timing:
- CV testing is anticipated to commence within the next month, following receipt of test kits at the laboratory.
- The FDA 510(k) submission is planned for H1 CY2027.
CLEO is developing a blood test for ovarian cancer, a disease with the highest five-year mortality rate of all cancers affecting women, with 51% of patients dying within five years.
Investors exploring how the company’s second program is progressing can read our full explainer on CLEO’s ovarian screening test results, which sets the prototype’s sensitivity and specificity against CA125 and the pre-set benchmarks.
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