ColoSTAT Achieves 91% Sensitivity in Final Validation, Seeks ISO Accreditation
Rhythm Biosciences has completed critical validation of its ColoSTAT colorectal cancer assay and submitted it for ISO15189 accreditation, paving the way for commercialisation. The test demonstrated strong clinical performance, highlighting its potential as a non-invasive diagnostic tool.
- Final validation of ColoSTAT assay completed with robust clinical data
- Submission made to NATA for ISO15189 accreditation inclusion
- ColoSTAT shows 91% sensitivity and 98% negative predictive value in clinical samples
- Manufactured at scale by Quansys Biosciences using validated processes
- Company plans to pursue commercial pathways and announce clinical partnerships
Validation Milestone Achieved
Rhythm Biosciences Ltd (ASX – RHY) has reached a significant milestone in the development of its ColoSTAT assay, a blood-based diagnostic test for colorectal cancer. The company announced the completion of the final full system validation of ColoSTAT, including kits, algorithm, and instrumentation, using an extensive range of clinical samples. This validation confirms the test’s robustness and reproducibility, essential prerequisites for regulatory approval and commercial rollout.
The validation was conducted using over 450 sample replicates under varying analytical conditions, demonstrating the assay’s consistency and reliability. ColoSTAT’s manufacturing partner, Quansys Biosciences, produced the kits through a scalable process, ensuring readiness for larger-scale production.
Strong Clinical Performance
Beyond analytical validation, ColoSTAT exhibited promising clinical performance in a study involving more than 300 clinical samples. The assay achieved a sensitivity of 91% for detecting colorectal cancer in individuals over 45 years old, a key demographic for screening. Equally important, the test showed a high negative predictive value of 98%, indicating its potential to safely rule out cancer in symptomatic patients.
This performance profile positions ColoSTAT as a valuable tool for early detection and triage, especially for patients reluctant to undergo stool-based screening or invasive colonoscopy procedures. Early diagnosis of colorectal cancer is critical, as it significantly improves treatment outcomes and survival rates.
Regulatory and Commercial Pathways
Following validation, Rhythm submitted the necessary documentation to the National Association of Testing Authorities (NATA) to include ColoSTAT within its ISO15189 laboratory accreditation scope. This accreditation is a vital regulatory step that supports the assay’s commercialisation and integration into clinical practice.
Dr David Atkins, CEO and Managing Director, expressed optimism about the progress, emphasizing the company’s focus on commercial pathways and upcoming clinical partnerships. These collaborations will be crucial for expanding ColoSTAT’s evidence base and market reach.
Broader Implications and Future Prospects
Colorectal cancer remains a leading cause of cancer mortality worldwide, and innovations like ColoSTAT could transform screening paradigms by offering a simple, blood-based alternative. Rhythm’s commitment to advancing early detection aligns with global healthcare priorities to reduce cancer burden and improve patient outcomes.
Looking ahead, the company’s geneType platform, which integrates genetic and clinical data for risk assessment across multiple diseases, complements ColoSTAT’s mission and may enhance personalized medicine approaches.
Bottom Line?
With validation complete and accreditation underway, Rhythm Biosciences is poised to bring a promising colorectal cancer test to market, but commercial success hinges on regulatory approval and strategic partnerships.
Questions in the middle?
- When will NATA approve ColoSTAT’s inclusion in the ISO15189 accreditation?
- What commercial partnerships will Rhythm Biosciences announce to support market entry?
- How will ColoSTAT’s pricing and reimbursement strategies impact adoption?
