Cleo Diagnostics selects Bio-Techne’s Ella platform to deliver ovarian cancer blood test
Cleo Diagnostics has selected Bio-Techne’s Ella platform as the immunoassay instrument for its ovarian cancer blood test, marking a significant step in the Cleo Diagnostics Ella Platform Partnership (ASX: COV). The selection aligns the Australian biotech with a NASDAQ-listed life sciences company that generated over $1.2 billion in net sales in fiscal 2025 and has approximately 3,100 employees worldwide. Binding agreement discussions are well progressed for analytical validation, with both parties aligned to enter a long-term manufacturing supply agreement following completion of these activities.
The partnership pairs Cleo’s proprietary biomarker panel with Bio-Techne’s next-generation automated ELISA technology. Bio-Techne has already commenced preliminary development activities in the United States, enabling immediate work upon formal engagement. This positions Cleo to progress analytical validation, complete clinical trial sample testing, and advance its 510(k) FDA submission with a manufacturing partner capable of supporting commercial scale.
What is the Ella platform and how does it work?
The Ella platform is an automated enzyme-linked immunosorbent assay (ELISA) platform. ELISA is a laboratory method used to detect specific proteins in blood samples. The Ella platform represents a next-generation approach, using microfluidic cartridges to measure Cleo’s proprietary biomarker panel with reduced manual input compared to conventional methods.
Patient samples follow a defined pathway from clinic to result:
- Blood collected via simple blood draw
- Sample processed using Cleo’s multi-biomarker test kit
- Ella platform analyses the biomarker panel in a pathology laboratory
- Report sent to patient’s doctor for assessment
Cleo has been using Ella in-house since September 2025 and has confirmed the platform’s capability to deliver its ovarian cancer technology. The platform uses microfluidic cartridges to measure the biomarker panel that forms the key inputs of Cleo’s algorithm, which underpins the company’s patented technology. For investors, the platform’s automation and reproducibility support both regulatory submission requirements and future commercial scalability. The ability to process samples consistently across laboratories strengthens the commercial proposition for pathology networks.
Technical advantages over conventional ELISA
The Ella platform delivers material performance improvements compared to traditional ELISA methods. These technical gains translate to practical benefits for clinical utility and commercial viability.
| Feature | Ella Platform | Traditional ELISA |
|---|---|---|
| Run time | 90 minutes total | 4+ hours per biomarker |
| Biomarker analysis | Simultaneous multiple | Sequential |
| Analytical sensitivity | Higher | Standard |
| Manual input | Reduced | Extensive |
| Reproducibility | Improved | Variable |
Faster processing times improve laboratory throughput. Higher analytical sensitivity and precision strengthen the quality of data being submitted to regulators. Improved reproducibility addresses a key commercial consideration, as pathology laboratories require assays that deliver consistent results across different operators and sites. These technical advantages position the Cleo Diagnostics Ella Platform Partnership (ASX: COV) to meet both regulatory standards and commercial laboratory requirements.
Path to FDA submission and commercialisation
Cleo has disclosed a seven-step pathway from binding agreement execution through to long-term commercial supply. Bio-Techne has already commenced preliminary development activities in the United States, allowing immediate commencement of work once the parties formally engage. The timeline to complete analytical validation will be confirmed upon signing.
The finished kits produced during analytical validation will test approximately 500 blood samples collected as part of Cleo’s pivotal clinical trial. These results will allow completion of the clinical trial and form the primary data package for the upcoming 510(k) FDA submission.
The disclosed next steps are:
- Execute binding agreement with Bio-Techne
- Commence kit manufacture for analytical validation
- Analytical validation
- US clinical trial sample testing
- Analysis and results
- FDA submission
- Long-term commercial supply agreement
The pathway provides visibility on key milestones toward US market entry. The fact that Bio-Techne has already begun preliminary work indicates alignment on technical requirements and commercial terms. Both parties are aligned to enter a long-term commercial supply agreement following successful completion of these activities, signalling mutual commercial commitment beyond the validation phase.
Why this partnership matters for investors
The platform selection represents a strategic de-risking step for Cleo’s commercialisation pathway. Rather than developing manufacturing capability in-house, the company has partnered with an established global supplier possessing the infrastructure and regulatory experience to support commercial scale.
This approach aligns with Cleo’s modular execution strategy, which targets surgical triage, recurrence, high-risk, and early-stage screening markets. The technology is underpinned by over 15 years of research and development at the Hudson Institute of Medical Research, with two clinical studies conducted across more than 500 patients. The intellectual property is protected by patents, and Cleo holds a worldwide exclusive licence to commercialise it.
About Bio-Techne
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for research and clinical diagnostic communities. With over $1.2 billion in net sales in fiscal 2025 and approximately 3,100 employees worldwide, the company brings established manufacturing and regulatory capabilities to the partnership.
Platform lock-in with a global supplier positions Cleo to scale manufacturing while maintaining focus on its core diagnostic intellectual property and clinical development. The alignment on a long-term supply agreement following validation suggests both parties view the commercial opportunity as viable. For investors, this reduces execution risk around manufacturing capability and provides a clearer line of sight to potential US market entry following FDA submission.
Strategic positioning for regulatory submission
The Cleo Diagnostics Ella Platform Partnership (ASX: COV) advances the company toward a defined regulatory endpoint. With binding agreement discussions well progressed, analytical validation timelines pending formal engagement, and Bio-Techne already undertaking preliminary development work, the pathway to testing pivotal trial samples is becoming operational rather than aspirational. The 510(k) FDA submission remains the near-term regulatory milestone, supported by a data package derived from approximately 500 clinical trial samples processed on a platform now confirmed as fit for purpose.
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