Rhythm’s ColoSTAT Blood Test Achieves NATA Accreditation, Boosting Colorectal Cancer Screening in Australia
Rhythm Biosciences has reached a significant regulatory milestone with its innovative blood test for colorectal cancer, ColoSTAT. Australia’s peak laboratory accreditation authority, the National Association of Testing Authorities (NATA), has officially confirmed that the ColoSTAT assay meets stringent international clinical laboratory standards. This accreditation is a crucial step, allowing the test to be offered as a validated clinical diagnostic service to healthcare professionals and patients across the nation.
NATA Accreditation: A Mark of Quality and Competence
The endorsement from NATA signifies that ColoSTAT adheres to the rigorous requirements of ISO 15189:2022. This globally recognised standard dictates the quality, competence, and traceability essential for medical laboratories. Following a thorough assessment, ColoSTAT has now been formally incorporated into the accredited scope of Rhythm Biosciences’ laboratory situated in Parkville, Victoria. This inclusion means the company is empowered to provide ColoSTAT as an accredited clinical diagnostic service, a development that promises to enhance the accessibility and reliability of colorectal cancer screening for Australians.
For clinicians and patients, this NATA accreditation serves as an independent guarantee. It confirms that the testing service operates under the highest recognised laboratory quality framework, ensuring analytical quality, laboratory competence, and the traceability of results in medical testing. This is particularly vital in the realm of cancer diagnostics, where accuracy and reliability are paramount.
A Key Step in Commercialisation and Market Entry
The NATA accreditation represents a pivotal moment in Rhythm Biosciences’ strategy to commercialise its blood-based diagnostic test for colorectal cancer. ColoSTAT is positioned as a potential alternative to more invasive screening methods currently available for colorectal cancer, a disease that ranks among the most prevalent cancers in Australia.
Effective screening is widely acknowledged as a cornerstone in improving survival rates for many cancers. By having ColoSTAT officially listed within the accredited scope of its Parkville laboratory, Rhythm is now poised to commence the accredited test’s rollout within the Australian market. The company has indicated plans to progressively enhance clinician awareness and establish robust referral pathways as part of this launch. Rhythm believes that this accreditation will be instrumental in fostering trust among healthcare providers and driving the adoption of ColoSTAT for routine clinical use.
Paving the Way for Reimbursement
Beyond its clinical implications, the NATA accreditation is also a significant enabler for Rhythm’s reimbursement pathway in Australia. Accreditation by NATA is considered a fundamental prerequisite for engaging with the Medical Services Advisory Committee (MSAC) concerning a potential listing on the Medicare Benefits Schedule (MBS).
Securing MBS reimbursement would dramatically broaden the accessibility of ColoSTAT, enabling the test to be subsidised through Australia’s universal healthcare system. Tests included in the MBS are typically more affordable for patients and, consequently, are more widely utilised by clinicians. This potential for MBS listing, supported by the NATA accreditation, could therefore lead to substantially greater clinical adoption of ColoSTAT.
Rhythm Biosciences has committed to keeping the market informed of its progress as it advances the commercial rollout of its ColoSTAT testing services.
“Strong, Independent Confirmation” of Quality
Dr. David Atkins, Managing Director and CEO of Rhythm Biosciences, highlighted the significance of this dual accreditation journey. He explained that the initial ISO 15189:2022 accreditation for the Parkville laboratory in November 2025 had already validated the quality and competence of their facility.
“Today, NATA has independently accredited ColoSTAT within our laboratory scope — confirming that the assay meets the internationally recognised standards for medical testing quality and technical performance,” Dr. Atkins stated.
He emphasised that these accreditations collectively represent the most stringent form of independent validation available for a clinical diagnostic service in Australia.
“This is not just a regulatory checkbox — it is a strong, independent confirmation of the science and the technical competence of our laboratory team that gives clinicians and patients real confidence in the test,” Dr. Atkins added. “We believe accreditation will support physician referral conversations and accelerate our pathway to broader adoption and reimbursement.”
