Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.
- Selection of Bio-Techne’s automated Ella™ ELISA platform for test development
- Improved assay speed, sensitivity, and automation over traditional methods
- Progressing towards binding agreement for analytical validation and clinical trial testing
- Data from validation to support pivotal FDA 510(k) submission
- Plans for long-term manufacturing supply agreement post-validation
A New Chapter in Ovarian Cancer Diagnostics
Cleo Diagnostics Ltd (ASX, COV) has announced a significant step forward in the development of its ovarian cancer blood test by selecting Bio-Techne’s Ella™ platform as the core immunoassay instrument. This move signals Cleo’s commitment to leveraging cutting-edge technology to deliver a more sensitive, faster, and automated diagnostic solution.
The Ella™ platform, an automated enzyme-linked immunosorbent assay (ELISA) system, offers a marked improvement over traditional ELISA methods. It reduces assay run times from over four hours to just 90 minutes, while simultaneously analysing multiple biomarkers with greater precision and reproducibility. This enhanced capability is critical for Cleo’s proprietary biomarker panel, which underpins its patented ovarian cancer detection algorithm.
Strategic Partnership and Validation Pathway
Cleo has been trialling the Ella™ platform in-house since September 2025, confirming its suitability for the company’s diagnostic technology. The two companies are now advancing discussions towards a binding agreement to commence analytical validation (AV) of Cleo’s test kits. Bio-Techne has already initiated preliminary development activities in the United States, positioning the partnership for a swift start once formalised.
The analytical validation phase will involve manufacturing test kits that will be used to analyse approximately 500 blood samples collected during Cleo’s pivotal clinical trial. The results from this phase are expected to be the cornerstone of Cleo’s forthcoming 510(k) submission to the U.S. Food and Drug Administration (FDA), a critical regulatory milestone for market entry.
Looking Ahead, Commercialisation and Market Impact
Following successful analytical validation and clinical testing, Cleo and Bio-Techne plan to enter a long-term commercial supply agreement. This arrangement will support scalable manufacturing and consistent supply of the test kits, facilitating broader market availability. For Cleo, this partnership not only accelerates its regulatory timeline but also enhances its capacity to meet the urgent global need for early and accurate ovarian cancer detection.
With ovarian cancer often diagnosed late due to subtle symptoms and lack of effective screening tools, Cleo’s blood test; backed by over 15 years of research at the Hudson Institute of Medical Research; could be transformative. Early detection significantly improves survival rates, and Cleo’s modular strategy aims to address multiple diagnostic needs including surgical triage and recurrence monitoring.
As Cleo moves closer to FDA submission, investors and the medical community will be watching closely to see how this collaboration with Bio-Techne translates into clinical and commercial success.
Bottom Line?
Cleo’s alliance with Bio-Techne sets the stage for a faster, more precise ovarian cancer test, with regulatory approval and market launch on the horizon.
Questions in the middle?
- When will the binding agreement with Bio-Techne be formally signed?
- What is the expected timeline for completing analytical validation and clinical trial testing?
- How will the Ella™ platform integration impact the cost and scalability of Cleo’s test kits?