Rhythm advances ColoSTAT rollout with TGA notification, GP software integration and 100+ collection sites
Rhythm Biosciences (ASX: RHY) has reported three simultaneous milestones in the commercial rollout of ColoSTAT, its blood-based colorectal cancer triage test, in an update released on 20 August 2026.
The developments span regulatory compliance, clinician ordering and patient access. ColoSTAT’s TGA in-house IVD notification has been accepted, ordering is now live within the MedicalDirector clinical software platform, and the collection-site network has passed 100 sites across Australia’s eastern states.
These milestones build on Rhythm’s previously announced commercialisation activities. Rather than marking first commercialisation, they represent progress in the infrastructure through which GPs order and patients access the test. Each step removes a practical barrier to routine ordering and broader adoption.
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TGA in-house IVD notification accepted
ColoSTAT has been accepted into the TGA In-House IVD Notification Database as an in-house in vitro diagnostic (IVD) test. According to Rhythm, this completes the notification step applicable to in-house IVDs used within the Company’s NATA-accredited laboratory, marking a further regulatory and compliance milestone.
The test is performed within Rhythm’s ISO 15189 NATA-accredited laboratory in Parkville, Melbourne. This is the established compliance pathway for Class 1–3 laboratory-developed IVDs used within an accredited laboratory under the applicable NPAAC/NATA framework.
The Company describes the notification as completing the final administrative step in the regulatory and compliance pathway supporting domestic commercialisation. The compliance chain already completed includes:
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Assay validation
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NATA assessment
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ISO 15189 accredited lab scope inclusion
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TGA in-house IVD notification accepted
MedicalDirector integration now live for GP ordering
The ColoSTAT test request form has been integrated into MedicalDirector, one of Australia’s leading general practitioner clinical software platforms, with ordering live from 1 August 2026. The test request form is the electronic order form a GP completes to refer a patient for testing.
From this date, GPs using MedicalDirector can order ColoSTAT within their existing clinical workflow rather than downloading and manually completing form details. Integration into commonly used GP software reduces the administrative steps required to order the test and supports its incorporation into routine workflows.
Rhythm noted it is now progressing equivalent integration with other platforms, with the objective of progressively broadening electronic ordering access across Australian GPs. Reducing friction at the point of ordering is a key adoption driver.
Collection network passes 100 sites across eastern states
The collection network now comprises more than 100 collection sites across New South Wales, Victoria and Queensland. Because ColoSTAT can only be ordered where a nearby collection centre is available to take a patient’s sample, each new site directly widens patient access.
The growth trajectory reflects continued momentum. Working with 4Cyte, Rhythm has prioritised regional hubs serving wide catchments and areas of high potential demand.
The initial 38-site network activated through 4Cyte in early March 2026 validated the end-to-end testing workflow from blood collection through to result reporting, establishing the commercial foundation that subsequent expansion has built upon.
| Milestone | Date | Collection Sites | Significance |
|---|---|---|---|
| Initial network | Early March 2026 | 38 sites | Initial commercial network |
| Network expansion | End March 2026 | 78 sites | More than doubled |
| Continued growth | August 2026 | 100+ sites | Continued expansion |
Recent activations spanned:
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NSW (Central Coast and Hunter — Toukley, Woy Woy, Dora Creek, Singleton)
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Regional Victoria (Hamilton, Shepparton, Ballarat, Sale)
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South-East Queensland (Tweed Heads, Toowoomba, Caloundra)
Why colorectal cancer testing matters
Colorectal cancer (CRC), also referred to as bowel cancer, is the second leading cause of cancer deaths globally. If diagnosed early, the disease can be curable, making accessible detection tools clinically valuable.
ColoSTAT is a simple blood-based test that measures five specific protein biomarkers indicating the likelihood of CRC. It is intended for individuals with symptoms associated with colorectal cancer.
The test is based on research from Australia’s CSIRO and is patent protected internationally.
What the rollout means for the investment case
The three milestones combine to address the key practical requirements for broader adoption: an accredited and compliant testing pathway, accessible clinician ordering, and convenient patient sample collection. Each removes a distinct barrier to GP ordering and patient access.
The update signals a strategic shift. With core infrastructure now in place, the Company’s stated focus is moving from establishing that infrastructure towards driving clinician engagement, patient access and utilisation of the test in the Australian market.
Dr David Atkins, CEO & Managing Director
“These are practical but important milestones in the commercial rollout. Our focus is increasingly shifting from establishing the infrastructure required to deliver ColoSTAT towards driving clinician engagement, patient access and test utilisation.”
What’s next for ColoSTAT
Rhythm indicated it will continue to expand the supporting infrastructure, including further GP ordering-system integrations and continued collection-network coverage across Australia.
With the accredited testing pathway, clinician ordering and patient collection now progressing in parallel, the next value driver is expected to centre on utilisation and uptake. No financial or utilisation figures were disclosed in the update.
The NHS evaluation of ColoSTAT, initiated in February 2026, positions the test within one of the world’s largest organised screening populations and represents a parallel commercial validation track to the Australian rollout currently underway.
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