Rhythm Biosciences Begins Commercial Sales of ColoSTAT® After ISO Accreditation
Rhythm Biosciences has begun commercialising ColoSTAT®, its blood-based colorectal cancer diagnostic test, following an updated ISO15189, 2022 accreditation. The test offers a new option for symptomatic patients where stool-based screening is unsuitable.
- ColoSTAT® commercialisation initiated after ISO15189 – 2022 accreditation update
- Blood-based colorectal cancer test targets symptomatic individuals avoiding stool tests
- Initial rollout via ColoSTAT® Access Program with select clinicians
- NATA accreditation review scheduled for January 2026 to formalise lab service
- Test based on CSIRO research measuring five protein biomarkers
A New Chapter for Colorectal Cancer Testing
Rhythm Biosciences Ltd has taken a significant step forward by commencing the commercialisation of ColoSTAT®, its innovative blood-based test for colorectal cancer detection. This move follows the company’s successful update and renewal of its ISO15189, 2022 accreditation, a key quality standard for medical laboratories. The accreditation upgrade not only validates the test’s clinical reliability but also marks Rhythm’s transition from development to market launch.
Addressing an Unmet Clinical Need
Colorectal cancer remains a leading cause of cancer deaths worldwide, and early detection is critical for improving patient outcomes. ColoSTAT® is designed specifically for symptomatic individuals who cannot or prefer not to undergo the traditional stool-based faecal immunochemical test (FIT). By offering a blood-based alternative, Rhythm aims to fill a gap in current diagnostic pathways, providing clinicians with a practical option during watchful waiting periods or when stool testing is not feasible.
Strategic Rollout and Data Generation
The initial commercial phase will be driven by the ColoSTAT® Access Program, which partners with selected clinical leaders to introduce the test to symptomatic patients. This program is intended to build clinician familiarity, generate valuable real-world evidence, and strengthen the clinical data supporting ColoSTAT® ahead of a broader market rollout. Such a phased approach reflects Rhythm’s commitment to evidence-based adoption and regulatory compliance.
Regulatory Milestones on the Horizon
Looking ahead, Rhythm has scheduled a variation to scope assessment with the National Association of Testing Authorities (NATA) for January 23, 2026. Successful completion of this assessment will formally accredit ColoSTAT® as a clinical laboratory service, enhancing clinician confidence and enabling scalable commercial operations. This regulatory milestone will be closely watched by investors and healthcare providers alike.
Innovation Rooted in Australian Research
ColoSTAT® leverages five specific protein biomarkers identified through research by Australia’s CSIRO, underpinning its diagnostic accuracy. The test’s patent protection internationally positions Rhythm Biosciences to potentially expand its reach beyond Australia. The company’s broader vision includes improving early cancer detection globally, reducing mortality rates, and alleviating healthcare costs associated with late-stage diagnoses.
Bottom Line?
As Rhythm Biosciences advances ColoSTAT® towards full accreditation and wider adoption, the coming months will be pivotal in defining its role in colorectal cancer diagnostics.
Questions in the middle?
- How will clinicians integrate ColoSTAT® alongside existing screening methods?
- What reimbursement pathways will support ColoSTAT®’s commercial scalability?
- Can real-world data from the Access Program accelerate broader regulatory approvals?
