How Rhythm Biosciences’ ColoSTAT® Kits Break New Ground in Cancer Detection
Rhythm Biosciences has advanced its ColoSTAT® diagnostic kits to final production validation, demonstrating consistent detection of colorectal cancer across all stages in a pivotal study. The company is gearing up for regulatory submission and commercial launch later this year.
- ColoSTAT® kits reach final production validation stage
- Study of 300 patient samples confirms detection across colorectal cancer stages I-IV
- Diagnostic performance meets clinical requirements for symptomatic patients
- Regulatory submission to NATA and commercial launch planned for late 2025
- Test offers a blood-based alternative for patients unable or unwilling to undergo current screening
Final Validation Milestone Achieved
Rhythm Biosciences Ltd (ASX, RHY), an Australian medical diagnostics innovator, has announced a significant advancement in its ColoSTAT® colorectal cancer detection test. The company has received its first batch of production-quality kits manufactured by Quansys Biosciences, marking the transition from development to final production validation. This milestone is critical as it confirms the test’s readiness for clinical and commercial use.
Consistent Performance Across Cancer Stages
In a study involving 300 patient blood samples, ColoSTAT® demonstrated consistent diagnostic accuracy across all colorectal cancer stages, from early Stage I to advanced Stage IV. This is particularly important because the test is designed for symptomatic patients who may present with varying disease severity. The ability to reliably detect cancer at any stage enhances ColoSTAT®’s clinical utility and potential impact on patient outcomes.
A Blood-Based Alternative to Screening
ColoSTAT® measures five specific protein biomarkers linked to colorectal cancer, offering a simple blood test alternative for individuals who are unable or unwilling to participate in conventional screening programs. Given colorectal cancer’s status as the second leading cause of cancer deaths globally, early and accessible detection methods like ColoSTAT® could play a vital role in reducing mortality and healthcare costs.
Regulatory and Commercial Outlook
Following this successful validation, Rhythm Biosciences plans to submit ColoSTAT® to the National Association of Testing Authorities (NATA) to include the test in its ISO15189-accredited laboratory portfolio. Pending regulatory approval, the company aims to launch ColoSTAT® commercially later in 2025. While the timeline for NATA approval remains uncertain, this step is essential for market entry and reimbursement pathways.
Looking Ahead
Rhythm Biosciences’ progress with ColoSTAT® underscores its commitment to transforming cancer diagnostics through innovative, patient-friendly solutions. The company also continues to develop its geneType platform, which integrates genetic and clinical data for broader disease risk assessments. Investors and healthcare providers alike will be watching closely as Rhythm moves toward commercialisation, potentially reshaping colorectal cancer detection and management.
Bottom Line?
With regulatory submission imminent, Rhythm Biosciences is poised to disrupt colorectal cancer diagnostics, pending final approvals.
Questions in the middle?
- What is the expected timeline for NATA regulatory approval and commercial launch?
- How will ColoSTAT® compete with existing colorectal cancer screening methods in the market?
- What further validation studies are planned to support broader clinical adoption?