Cleo Diagnostics Confirms Robust Performance in 120-Sample Alpha Test
Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.
- Alpha testing completed on commercial prototypes with 120 blood samples
- Assay kits demonstrated robust, reproducible performance meeting design specifications
- Confirmed ability to distinguish benign from malignant ovarian disease
- Next phase includes assay optimisation, beta testing, and manufacturing scale-up
- Partnership with FDA-approved manufacturer R&D Systems supports regulatory pathway
Alpha Testing Milestone Achieved
Melbourne-based Cleo Diagnostics Limited (ASX:COV) has announced a significant step forward in the development of its ovarian cancer diagnostic test, successfully completing alpha testing of its pre-surgical triage assay kits. This phase involved rigorous in-house evaluation of 120 blood samples using commercial prototypes manufactured by R&D Systems, an FDA-approved contract manufacturing organisation. The results confirmed that all assay components met design specifications and demonstrated robust and reproducible performance across multiple validation metrics.
Most notably, the assay kits were able to reliably differentiate between benign and malignant ovarian disease, consistent with Cleo’s previously published research. This validation is crucial as it underpins the test’s clinical utility in improving early diagnosis and treatment decisions for ovarian cancer, a disease with a notoriously low five-year survival rate of 49% worldwide.
Strategic Development and Manufacturing Scale-Up
With alpha testing complete, Cleo is now advancing to the next phase of development. This includes assay optimisation, beta testing, and scaling up manufacturing capabilities in parallel with ongoing clinical trials in the United States. These steps are designed to ensure that the assay kits used in clinical studies are materially identical to those intended for commercial release, thereby streamlining the regulatory approval process with the FDA.
The company’s collaboration with R&D Systems, a subsidiary of Bio-Techne Corporation based in Minneapolis, provides a strong manufacturing and development partner to support this scale-up. This partnership is integral to Cleo’s strategy to bring its patented CXCL10 biomarker-based test to market efficiently and with regulatory compliance.
Clinical and Market Implications
Ovarian cancer remains a critical unmet medical need, with over 300,000 new cases diagnosed annually worldwide. Early and accurate diagnosis is essential to improving patient outcomes, and Cleo’s blood test aims to fill this gap by providing a simple, reliable tool to guide pre-surgical decision-making. The test’s compatibility with existing diagnostic laboratory equipment further enhances its potential for widespread adoption.
CEO Dr Richard Allman highlighted the significance of this milestone, stating that the successful alpha testing clears the path toward scaled manufacturing and regulatory clearance. The company’s modular development approach also positions it to expand its diagnostic offerings to cover recurrence monitoring, high-risk screening, and early-stage detection in the future.
Bottom Line?
Cleo Diagnostics’ alpha testing success sets the stage for critical regulatory milestones and potential market entry in ovarian cancer diagnostics.
Questions in the middle?
- What is the expected timeline for completing beta testing and submitting to the FDA?
- How will ongoing clinical trial results impact the regulatory approval process?
- What are the commercialisation plans and potential market adoption strategies post-FDA approval?
