Cleo Diagnostics Enters Manufacturing Phase to Prepare FDA Submission Package
CLEO moves into manufacturing phase ahead of FDA submission
Cleo Diagnostics has commenced a staged manufacturing and development programme with Bio-Techne Corporation to produce ovarian cancer test kits, following completion of sample collection for its pivotal U.S. clinical trial on 31 March 2026. The Company has transitioned from clinical recruitment into the final execution phase covering analytical validation and clinical sample testing, marking a key milestone towards FDA 510(k) submission.
Bio-Techne (NASDAQ: TECH) is a global life sciences company with proven capability in immunoassay development and commercial-scale manufacturing. The company generated over $1.2 billion in net sales in fiscal 2025 and employs approximately 3,100 people worldwide. Patients for CLEO’s trial were recruited across 19 clinical trial sites.
Manufacturing commencement de-risks the pathway to FDA 510(k) submission by validating production capability before full-scale rollout.
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What is FDA 510(k) clearance and why it matters
FDA 510(k) clearance is a premarket submission pathway that requires a medical device manufacturer to demonstrate their product is substantially equivalent to an already legally marketed device. This regulatory route is significant for medical diagnostics companies seeking U.S. market access because it provides a streamlined pathway compared to the more rigorous Premarket Approval process required for novel, higher-risk devices.
Analytical validation is a mandatory requirement for 510(k) submission. It demonstrates reliable and reproducible test performance before clinical data analysis can proceed. For CLEO, the evidence package generated from analytical validation and clinical sample testing forms the core submission materials that will be presented to the FDA.
FDA clearance opens access to the world’s largest healthcare market. The staged manufacturing approach reduces risk of submission delays by identifying and resolving technical issues early in the development process.
Staged manufacturing programme structure
The phased approach focuses initial work on development and optimisation of critical assay components, including antibody production and preparation across selected biomarkers within CLEO’s proprietary biomarker panel. This foundational work ensures assay consistency, reproducibility and manufacturing readiness.
CLEO’s partnership with Bio-Techne centres on the Ella platform, announced 18 February 2026, as the dedicated instrument for the Pre-Surgical Ovarian Cancer Test. The Company has confirmed the Ella platform’s capability to deliver the biomarker panel with high sensitivity, precision and reproducibility through in-house testing.
Staging reagent development, antibody preparation and assay optimisation reduces technical and manufacturing risk ahead of full-scale kit production. This allows early identification of manufacturing issues before committing to full-scale production runs.
Next steps in the staged programme:
- Completion of reagent and antibody production, and finalisation of assay components
- Manufacture of multiple production batches of test kits for use on the Ella platform supporting analytical validation
- Completion of analytical validation to demonstrate consistent and reproducible assay performance
- Testing of clinical trial samples using the validated test configuration
- Analysis of clinical trial data to generate the evidence package for FDA 510(k) submission
CEO commentary
Richard Allman, Chief Executive Officer
“Commencing our manufacturing program with Bio-Techne is an important milestone for CLEO as we transition from clinical sample collection into AV and sample testing. The staged approach allows us to optimise critical assay components and reduce technical and manufacturing risk ahead of full-scale kit production. Importantly it enables generation of the data required to support our planned FDA 510(k) submission. As a global leader in assay manufacturing, we have full confidence in Bio-Techne’s ability to help deliver our project. With clinical sample collection completed and manufacturing activities now underway, CLEO is nearing the final execution phase of its U.S. clinical and regulatory program.”
CLEO’s ovarian cancer test and the clinical opportunity
CLEO’s product is a blood test for ovarian cancer diagnosis based on the patented biomarker CXCL10, which is produced early and at high levels by ovarian cancers but is largely absent in non-malignant disease. The test aims to distinguish benign from malignant growths using a standard format compatible with existing diagnostic laboratory equipment used by laboratories worldwide.
The clinical unmet need is significant. Accurate early detection could shift survivability for ovarian cancer substantially, as has been demonstrated with other cancers where early diagnosis improves patient outcomes. The test is designed to address surgical triage by providing clinicians with objective data to inform treatment decisions for patients presenting with adnexal masses.
CLEO’s platform is backed by over 15 years of R&D at the Hudson Institute of Medical Research. The scientific foundation includes two clinical studies conducted with over 500 patients. The Company holds a worldwide exclusive licence to commercialise the intellectual property underpinning its operations and the ovarian cancer tests.
| Development Milestone | Status | Significance |
|---|---|---|
| Clinical sample collection | Complete (31 March 2026) | Pivotal U.S. trial fully recruited across 19 sites |
| Manufacturing programme | Commenced (April 2026) | Test kit production underway with Bio-Techne |
| Analytical validation | Pending | Mandatory FDA requirement to demonstrate assay performance |
| FDA 510(k) submission | Pending | Regulatory pathway to U.S. market access |
The Pre-Surgical Ovarian Cancer Test addresses a significant clinical gap where accurate triage of adnexal masses can improve patient outcomes and reduce unnecessary surgeries. By providing objective biomarker data, the test aims to help clinicians identify which patients require immediate surgical intervention versus ongoing monitoring.
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Forward momentum into final execution phase
Sample collection is complete, manufacturing is underway, and analytical validation with clinical sample testing lies ahead. The data generated from these activities forms the core evidence package for FDA 510(k) submission.
CLEO’s staged manufacturing approach positions the Company to identify and resolve technical challenges early, reducing the risk of delays when full-scale production and regulatory submission commence. The partnership with Bio-Techne brings established expertise in immunoassay development and commercial-scale manufacturing to support CLEO’s transition from development into regulatory execution.
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