Rhythm Biosciences (ASX: RHY) has enrolled the first physician participant in its Rhythm Biosciences ColoSTAT Access Program, marking the blood-based colorectal cancer test’s entry into structured commercial deployment. The milestone represents Rhythm’s first pathway to routine paid clinical use and signals the company’s transition from a research-focused organisation to a commercial-stage business.
Rhythm Biosciences enrols first physician in ColoSTAT Access Program
The Rhythm Biosciences ColoSTAT Access Program establishes a controlled framework for introducing ColoSTAT into routine clinical practice in Australia. The programme is capped at 20 participants, with each enrolled physician receiving an initial allocation of tests at no cost to establish routine test ordering and delivery processes. Once participating clinicians and the company confirm that patient safety and clinical efficacy protocols are functioning effectively, further tests will be supplied on standard commercial terms.
Continued use of ColoSTAT after the initial allocation is expected to occur on a paid basis, subject to the clinician’s independent clinical judgement. Participation does not require physicians to commit to specific testing volumes, but the structure is designed to support transition to routine clinical use and ongoing ordering under commercial terms where clinicians elect to continue using ColoSTAT.
The programme will enable Rhythm to strengthen the clinical and commercial value proposition for ColoSTAT, demonstrate demand for a blood-based colorectal cancer testing alternative, and refine operational workflows for broader market deployment. Participating clinicians will provide summary clinical data to support the continued development of clinical evidence.
How the Access Program works
The programme operates through a two-phase structure designed to ensure patient safety whilst transitioning physicians to commercial terms.
| Phase | Description | Commercial Outcome |
|---|---|---|
| Initial Allocation | Physicians receive ColoSTAT tests at no cost to establish routine ordering and delivery processes | Workflow validation and safety protocols confirmed |
| Transition Period | Company and participant confirm patient safety and clinical efficacy protocols are functioning effectively | Foundation established for ongoing commercial use |
| Commercial Terms | Further tests supplied at standard commercial pricing, subject to clinician’s independent clinical judgement | Pathway to recurring test revenue established |
For investors, the transition mechanism from free allocation to paid commercial terms creates a pathway to recurring revenue whilst building the real-world evidence base required for future reimbursement applications and partner negotiations. The programme represents Rhythm’s first structured commercial deployment of ColoSTAT and an important step in establishing routine clinical ordering behaviour.
Why blood-based colorectal cancer screening matters
Colorectal cancer is the second leading cause of cancer death globally, yet screening rates remain low due to the invasive nature of current screening methods. Traditional screening options such as colonoscopy, whilst effective, present barriers to participation that contribute to late-stage diagnoses when treatment outcomes are less favourable.
ColoSTAT offers a simple blood test alternative that measures five specific protein biomarkers indicating the likelihood of colorectal cancer. The test is intended for individuals with symptoms associated with colorectal cancer and has the potential to dramatically improve screening participation rates by removing the procedural barriers associated with existing methods.
For Rhythm, the large addressable market combined with clear unmet need positions ColoSTAT to capture demand from patients who might otherwise avoid or delay screening. The enrolment of the first Access Program participant provides early validation of clinician engagement and potential demand for a more accessible blood-based testing option.
CEO outlines commercial vision
Management has emphasised that the milestone marks a fundamental shift in the company’s profile.
Dr David Atkins, CEO & Managing Director
“This is exactly the kind of milestone our stakeholders have been waiting for—tangible evidence that ColoSTAT is transitioning from concept to commercial reality.”
Dr Atkins noted that the programme provides the commercial framework needed to support broader market entry, enabling the company to establish clinician relationships, validate workflows, and build the real-world evidence base that underpins long-term adoption and strategic partnerships. He highlighted that the programme is designed to transition participating clinicians to routine paid clinical use following initial allocations, providing an important step toward sustainable commercial deployment.
Strategic milestones and next steps
With the first participant now enrolled, Rhythm has outlined the following priorities for the Access Program’s expansion and commercialisation pathway:
- Expand clinician participation in the Access Program with the objective of increasing paid clinical utilisation following initial allocations
- Generate real-world clinical and operational data to support reimbursement and partner engagement
- Progress discussions with potential commercial partners and distributors
- Continue preparation for broader market entry
Each milestone serves to de-risk the commercial thesis and advance Rhythm’s position as a commercial-stage diagnostics company. Real-world clinical and operational data generated through the programme will be critical for future reimbursement applications and partnership discussions, both of which are key components of Rhythm’s broader market access strategy.
The company has indicated it will provide further updates as additional milestones in the Access Program are achieved. Physician participants in the programme will remain anonymous for patient privacy reasons, and participants retain the option to terminate their involvement at any point.
Building the investment case
The Rhythm Biosciences ColoSTAT Access Program represents a significant inflection point in the company’s development trajectory. The programme establishes Rhythm’s first structured commercial deployment of ColoSTAT and creates a foundation for future market access, partnership, and distribution strategies.
For investors, demonstrating utilisation under commercial terms and real-world adoption are key milestones in validating the product-market fit hypothesis. The transition from initial free allocation to paid commercial terms provides a pathway to recurring test revenue, whilst the real-world data collected through the programme will underpin long-term adoption strategies and strategic partnerships.
Early commercial traction through the Access Program validates that clinicians see value in a blood-based colorectal cancer screening alternative and are willing to integrate ColoSTAT into routine clinical practice. The evidence base generated through clinician participation will be critical for broader market access discussions, including reimbursement pathways and distribution partnerships that can accelerate adoption beyond the 20-participant cap in Australia.
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