Rhythm Biosciences Hits 16 Clinicians in Push to Unlock Bowel Cancer Test Reimbursement

By Josua Ferreira -

ColoSTAT Access Program reaches 16 enrolled clinicians across Australia

Rhythm Biosciences (ASX: RHY) has announced that its ColoSTAT Clinical Access Program has reached 16 enrolled clinicians across key Australian healthcare centres, marking a meaningful milestone in the company’s commercial and clinical development strategy for its blood-based colorectal cancer triage test.

Key highlights from the announcement include:

  • 16 clinicians are now enrolled in the ColoSTAT Clinical Access Program across Australia
  • Participants include senior gastroenterologists and surgeons from both private and public health sectors
  • Enrolled clinicians are drawn from Sydney, Melbourne, Brisbane, and surrounding metropolitan areas
  • The Program operates in addition to routine ColoSTAT sales, generating structured real-world evidence to support future reimbursement and broader commercialisation

Why real-world evidence is the key to unlocking diagnostic reimbursement

For investors tracking the commercialisation arc of diagnostic technologies, understanding the role of real-world evidence (RWE) is essential to contextualising Rhythm’s current strategy.

What is real-world evidence and why does it matter?

Real-world evidence refers to data collected from everyday clinical practice rather than controlled clinical trials. Unlike trial data gathered under tightly managed conditions, RWE captures how a diagnostic test performs across a diverse range of patients, clinicians, and healthcare environments in routine settings.

Payers, health technology assessment (HTA) bodies, hospital networks, and clinical guideline developers increasingly use RWE when evaluating emerging diagnostic technologies. For ColoSTAT, establishing a strong real-world evidence base is a necessary step toward demonstrating clinical utility to the stakeholders who ultimately control access and reimbursement.

What ColoSTAT’s Access Program is designed to collect

The Program provides a structured mechanism for gathering data on clinician experience, patient profiles, clinical workflows, and test outcomes within Australian healthcare settings. This data is expected to demonstrate ColoSTAT’s clinical utility, workflow integration, and broader value proposition to hospitals, health networks, insurers, and government reimbursement authorities.

The calibre of participants is particularly notable. Experienced specialists are typically selective when adopting new diagnostic technologies, meaning the involvement of senior gastroenterologists and surgeons signals growing confidence in the science underpinning ColoSTAT and the unmet clinical need it addresses.

CEO & Managing Director, Dr David Atkins

“Reaching 16 enrolled participants in the ColoSTAT® Access Program is a meaningful milestone for the Company and an important indicator of growing clinical engagement with ColoSTAT®. The calibre of clinicians who have joined the Program — including senior gastroenterologists and surgeons — reflects increasing confidence in ColoSTAT® as a practical frontline triage tool for symptomatic patients. The Access Program is doing exactly what it was designed to do: placing ColoSTAT® in the hands of experienced clinicians, generating structured real-world evidence, and building the clinical foundations required for broader commercial adoption.”

The strategic roadmap from clinical adoption to market access

How the Access Program fits the broader commercialisation strategy

The Rhythm Biosciences ColoSTAT Access Program is positioned as a disciplined, cost-effective bridge between initial commercialisation and broader market access. Rather than replacing routine sales activity, it runs alongside it, generating the structured clinical data that supports three specific commercial goals: reimbursement discussions, clinical guideline inclusion, and long-term market penetration.

Enrolment is expected to continue building over coming months as awareness of the Program expands within the clinical community.

Program Element Current Status Strategic Purpose Next Step
Clinician enrolment 16 enrolled Real-world evidence generation Continued expansion
Specialities Gastroenterologists & surgeons Validate clinical utility Broader specialty inclusion
Geographies Sydney, Melbourne, Brisbane National footprint Additional centres
Data collection Underway Support reimbursement pathway Future insights reporting

What investors should watch for next

Rhythm Biosciences has indicated it intends to provide further updates on Program progress and, over time, share insights from the real-world clinical data being generated. The company’s stated focus is on generating credible, structured clinical data to strengthen ColoSTAT’s long-term commercial positioning, support future reimbursement pathways, and support potential inclusion in clinical guidelines.

As management has noted, meaningful commercial adoption for diagnostic technologies takes time and requires strong clinical validation. The current milestone reflects early-stage momentum that is consistent with that trajectory, rather than an indication of imminent revenue or reimbursement approval.

Three key indicators investors should monitor going forward:

  1. Enrolment growth — continued expansion of enrolled clinicians across additional healthcare centres and specialist networks
  2. Data insights releases — updates from the real-world clinical data being collected through the Program, expected to be shared over time
  3. Reimbursement pathway announcements — any formal developments related to reimbursement discussions, HTA submissions, or clinical guideline processes supported by Program data

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Frequently Asked Questions

What is the Rhythm Biosciences ColoSTAT Access Program?

The ColoSTAT Access Program is a structured clinical initiative run by Rhythm Biosciences (ASX: RHY) that places its blood-based colorectal cancer triage test in the hands of experienced clinicians across Australia, generating real-world evidence to support future reimbursement and broader commercial adoption.

How many clinicians are enrolled in the ColoSTAT Clinical Access Program?

As of the latest announcement, 16 clinicians are enrolled in the ColoSTAT Clinical Access Program, including senior gastroenterologists and surgeons from private and public health sectors across Sydney, Melbourne, and Brisbane.

Why is real-world evidence important for ColoSTAT's reimbursement pathway?

Payers, health technology assessment bodies, and hospital networks increasingly require real-world evidence — data from everyday clinical practice rather than controlled trials — to evaluate diagnostic technologies, making the Access Program a necessary step toward securing reimbursement for ColoSTAT in Australia.

What milestones should investors watch for with Rhythm Biosciences ColoSTAT?

Investors should monitor three key indicators: continued growth in enrolled clinicians across additional healthcare centres, the release of data insights from the real-world clinical evidence being collected, and any formal announcements related to reimbursement discussions, HTA submissions, or clinical guideline inclusion.

Does the ColoSTAT Access Program replace routine ColoSTAT sales activity?

No — the ColoSTAT Access Program operates in addition to routine ColoSTAT sales, meaning commercial sales activity continues alongside the structured evidence generation designed to support future reimbursement and market access goals.

Josua Ferreira
By Josua Ferreira
Partnership Director
Josua Ferreira holds a Bachelor of Commerce in Marketing and Advertising and brings a background in publication, business development, and ASX market storytelling. He has worked with listed companies across the resource sector and broader market, combining sharp commercial instincts with a genuine commitment to keeping investors informed.
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