Updated Accreditation Enables Market Entry
Rhythm Biosciences (ASX: RHY) has begun commercialising its blood-based colorectal cancer test, ColoSTAT®, following the renewal of the company’s ISO15189:2022 laboratory accreditation. The update allows Rhythm to transition from development to market launch, enabling the test to be offered initially through its certified Melbourne laboratory.
ColoSTAT® is designed for symptomatic individuals who cannot or will not undertake stool-based screening. This creates a new clinical pathway in a segment where alternative diagnostic options are limited. Early testing access may help reduce time to further investigation by giving clinicians a simpler, laboratory-run method to assess colorectal cancer probability.
First Phase: ColoSTAT® Access Program
Commercialisation begins with the ColoSTAT® Access Program, which partners with selected clinical leaders. The initiative enables participating clinicians to offer ColoSTAT® directly to patients. It is also expected to generate real-world data to support future regulatory and commercial steps as Rhythm builds volume and operational capability.
The company will undertake a variation-to-scope assessment with the National Association of Testing Authorities (NATA) on 23 January 2026. A successful assessment would formally affirm ColoSTAT® as a fully accredited laboratory service and expand the test’s scalability across broader clinical settings.
Management
Chief Executive Officer Dr David Atkins stated, “This is welcome news for the many individuals in Australia who are unable or unwilling to use the current gold standard for bowel cancer detection.”
Chairman Gavin Fox-Smith said, “Initiating the commercialising of ColoSTAT® before the end of 2025 has been a consistent and visible milestone communicated by the team and I’m delighted to see the business continue to meet its commitments.”
These comments reinforce the importance of establishing ColoSTAT® as a practical diagnostic option. Blood-based testing remains an emerging category within colorectal cancer screening, and Rhythm’s approach targets a specific clinical gap that has not been well addressed by existing tools. The launch also positions the company to participate more directly in the growing demand for minimally invasive diagnostic technologies.
ColoSTAT® and Its Clinical Role
ColoSTAT® measures five protein biomarkers associated with colorectal cancer. It is intended for symptomatic patients, providing clinicians with an alternative assessment method during watchful waiting periods or when standard screening is unsuitable. The test is based on CSIRO research and is patent-protected internationally.
