Rhythm Biosciences completes first ColoSTAT sale, validates commercial pathway
Rhythm Biosciences (ASX: RHY) has completed its first commercial sale of the ColoSTAT blood-based colorectal cancer test, marking the commencement of the company’s commercial clinical diagnostic testing operations. The milestone confirms the full clinical pathway has been validated, from blood draw through to result delivery to the ordering clinician.
With 5 participating sites already onboarded in Victoria and New South Wales, the company is positioned to scale immediately through its commercial partner, 4Cyte Pathology.
The successful completion confirms that Rhythm Biosciences (ASX: RHY) has moved from pre-revenue development into commercial operations with a proven, repeatable process. The test was conducted at the company’s clinical laboratory in Parkville, VIC, with the clinic invoiced directly for the service.
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How the ColoSTAT testing pathway works
The end-to-end testing process integrates seamlessly into existing clinical and pathology workflows without requiring new infrastructure. The pathway operates as follows:
- Blood sample collected at partner site (4Cyte Pathology)
- Sample transported to Rhythm’s clinical laboratory in Parkville, VIC
- Sample processed using the ColoSTAT assay
- Results reported to the ordering clinician
- Clinic invoiced directly for the testing service
The completion of this first commercial test demonstrates that sample collection, logistics, assay processing, and result reporting are all functioning effectively within a routine clinical setting. This validation de-risks commercial execution and confirms the service is ready for volume scaling, with all operational elements proven in a live clinical environment.
What is ColoSTAT and why does early detection matter?
Colorectal cancer, also referred to as bowel cancer, is the second leading cause of cancer deaths globally. The ColoSTAT Test is a blood-based diagnostic that measures five specific protein biomarkers indicating the likelihood of colorectal cancer.
The test is intended for individuals with symptoms associated with colorectal cancer, offering a simpler alternative to invasive diagnostic procedures.
The technology originated from Australia’s CSIRO and is patent protected internationally. Early detection of colorectal cancer significantly improves survival outcomes and reduces healthcare costs. If diagnosed early, colorectal cancer can be curable, making accessible and patient-friendly testing methods a critical component of reducing mortality rates.
Blood-based cancer detection represents a significant market opportunity. ColoSTAT addresses a large unmet clinical need with a patient-friendly approach that requires only a simple blood draw rather than more complex diagnostic procedures.
Scaling strategy through physician outreach and the ColoSTAT Access Program
Rhythm Biosciences is pursuing a two-pronged approach to commercial expansion: direct contact with primary care physicians combined with the structured ColoSTAT Access Program. The Access Program was announced on 11 February 2026 and provides a structured entry point for clinicians to begin ordering ColoSTAT tests.
Five participating sites in Victoria and New South Wales were already onboarded ahead of the first test completion. The Program allows Rhythm to collect valuable clinical data alongside commercial growth, supporting future regulatory or commercial milestones while building test volumes.
Updates on test volume growth are expected in quarterly reporting as the company scales its operations.
| Scaling Channel | Status | Purpose |
|---|---|---|
| Direct physician outreach | Active | Build test volumes with primary care |
| ColoSTAT Access Program | 5 sites onboarded | Structured clinician entry point + data collection |
| 4Cyte Pathology partnership | Operational | Sample collection infrastructure |
The infrastructure and partnerships are in place. This is now an execution and volume growth story, with the company positioned to expand test volumes immediately through validated operational pathways.
CEO commentary on commercial readiness
Dr. David Atkins, Managing Director and CEO, emphasised the significance of completing the first commercial test and the company’s readiness to scale operations. His commentary reinforces confidence in the pathway and near-term growth trajectory.
Dr. David Atkins, Managing Director and CEO, Rhythm Biosciences
“The completion of the first commercial ColoSTAT test sale is an important operational milestone for Rhythm. We have built a pathway that is practical for clinicians and seamless for patients, and today’s result demonstrates that the full end-to-end process works as intended. We have the infrastructure, the logistics, and the partnerships in place to scale from here, and we look forward to reporting on test volume growth in the coming months.”
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What investors should watch for next
With commercial validation complete, the investment thesis now hinges on adoption rates and revenue trajectory. Key metrics and catalysts investors should monitor include:
- Test volume growth updates in quarterly reports as the company scales from the initial commercial sale
- Expansion of participating sites beyond the initial 5 locations in Victoria and New South Wales
- Potential for additional pathology partnerships to extend geographic reach and sample collection infrastructure
- Clinical data collection from the ColoSTAT Access Program supporting future regulatory or commercial milestones
- Direct physician adoption rates as the company implements its primary care outreach strategy
The company has confirmed it will provide updates on commercial progress and adoption rates through regular quarterly reporting. The successful completion of this commercial milestone establishes a foundation for near-term revenue growth as the company executes its scaling strategy across established clinical and pathology networks.
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