- 01Cleo taps Asuragen/Bio-Techne for pivotal CV
- 021,300+ samples across disease/controls
- 03FDA 510(k) filing planned for H1 2027
Cleo Diagnostics (ASX: COV) has engaged Asuragen, the Clinical Laboratory Improvement Amendments (CLIA)-certified US laboratory of Bio-Techne Corporation, to conduct pivotal clinical validation (CV) of its pre-surgical ovarian cancer test.
The program will generate clinical performance data from more than 1,300 samples across patients with ovarian disease, other benign or malignant conditions and healthy individuals.
Cleo will use the work to establish the test’s positive and negative predictive value (PV), sensitivity, and specificity in its intended clinical setting.
The engagement extends Cleo’s relationship with Bio-Techne across commercial test kit manufacture, the Ella diagnostic platform, and pivotal US clinical testing as the company advances towards a planned US Food and Drug Administration 510(k) submission.
Asuragen Validation Role
Cleo has executed a statement of work with Asuragen to evaluate the performance of the commercial test in the intended patient population and relevant control groups.
The pivotal clinical performance study will assess about 600 samples collected through Cleo’s US pivotal clinical trial across 19 sites, focusing on the test’s ability to distinguish benign from malignant ovarian disease.
A clinical specificity study will examine about 570 samples from patients with non-ovarian benign or malignant conditions to assess how specifically the test identifies ovarian cancer.
A further study involving about 300 healthy individuals will establish expected value ranges in a non-disease population, providing another component of the overall clinical evidence package.
Together, the three studies are designed to provide the clinical performance data Cleo needs to support regulatory assessment of the pre-surgical ovarian cancer test.
FDA Pathway in Focus
Asuragen’s appointment follows Cleo’s receipt of the first production batch of commercial test kits from Bio-Techne, which are progressing through internal verification before formal analytical validation (AV) begins.
CV is intended to demonstrate that the commercial assay performs reliably in its intended clinical setting, while AV will generate the analytical performance data required alongside the clinical evidence.
Cleo expects the combined CV and AV results to form the core evidence base for its planned FDA submission, with the current development pathway targeting that filing in the first half of calendar year 2027.
The company’s staged pathway places AV ahead of clinical sample testing and subsequent analysis of trial results, followed by the FDA submission and, subject to approval, commercial launch of the ovarian cancer test.
Cleo is developing the blood test as the first stage of a broader ovarian cancer diagnostics strategy that also envisages recurrence monitoring and, ultimately, screening applications.
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