Rhythm Biosciences has achieved a significant regulatory milestone with NATA accreditation for its ColoSTAT® blood-based colorectal cancer test, enabling its commercial rollout in Australia and strengthening reimbursement prospects.
- ColoSTAT® accredited under ISO 15189:2022 by NATA
- Test validated for clinical diagnostic use in Australia
- Enables commercial offering to clinicians and patients
- Supports pathway for Medicare Benefits Schedule reimbursement
- Accreditation confirms high standards of test quality and laboratory competence
Accreditation Milestone Achieved
Rhythm Biosciences Ltd (ASX:RHY) has announced that its ColoSTAT® blood-based colorectal cancer test has received formal accreditation from the National Association of Testing Authorities (NATA), Australia’s peak laboratory accreditation body. This recognition confirms that ColoSTAT® meets the stringent ISO 15189:2022 standards for clinical laboratory testing, validating both the test’s technical performance and the competence of Rhythm’s Parkville laboratory.
The accreditation process involved a thorough review of ColoSTAT®’s validation data and clinical application in line with the National Pathology Accreditation Advisory Council’s requirements. This independent endorsement provides clinicians and patients with authoritative assurance that the test is reliable, traceable, and suitable for clinical use.
Commercial Launch and Market Implications
With ColoSTAT® now formally included within Rhythm’s accredited laboratory scope, the company is positioned to commence offering the test as a clinical diagnostic service across Australia. This milestone is a critical step in Rhythm’s commercial strategy, enabling the company to engage with healthcare providers and build referral pathways for the blood test, which aims to detect colorectal cancer at an early, more treatable stage.
Importantly, NATA accreditation is a prerequisite for discussions with the Medical Services Advisory Committee (MSAC) regarding potential inclusion of ColoSTAT® on the Medicare Benefits Schedule (MBS). Securing MBS listing would facilitate reimbursement, making the test more accessible and encouraging broader clinical adoption within Australia’s healthcare system.
Leadership Perspective
Dr David Atkins, CEO and Managing Director of Rhythm Biosciences, highlighted the significance of this achievement: "This accreditation is not just a regulatory checkbox but a robust, independent validation of the science and technical quality behind ColoSTAT®. It gives clinicians and patients confidence in the test and supports our efforts to accelerate adoption and reimbursement."
Dr Atkins also noted that the accreditation journey began with the laboratory’s ISO 15189:2022 certification in late 2025, and the inclusion of ColoSTAT® within that scope completes the rigorous validation process.
Looking Ahead
Rhythm plans to progressively increase clinician awareness and patient access to ColoSTAT® as part of its rollout strategy. The company will provide further updates on commercial progress and reimbursement discussions in due course. Given colorectal cancer’s status as a leading cause of cancer mortality, the availability of a simple, blood-based diagnostic test could have meaningful clinical and economic impacts.
Bottom Line?
NATA accreditation marks a pivotal step for Rhythm Biosciences, setting the stage for ColoSTAT®’s commercial success and potential Medicare reimbursement.
Questions in the middle?
- What is the expected timeline for securing Medicare Benefits Schedule listing for ColoSTAT®?
- How quickly will clinicians adopt ColoSTAT® testing in routine colorectal cancer diagnostics?
- What are the commercial rollout plans beyond Australia, if any?