Rhythm Biosciences Completes First ColoSTAT Sale and Opens Door to Immediate Scale
Rhythm Biosciences completes first commercial ColoSTAT sale, validating pathway for scale-up
Rhythm Biosciences (ASX: RHY) has completed the Rhythm Biosciences ColoSTAT First Sale, marking the transition from development to revenue-generating operations for its blood-based colorectal cancer test. The milestone validates the full end-to-end clinical pathway, from blood collection through to result delivery, positioning the company to immediately scale testing volumes through participating clinicians.
The first patient blood samples were collected by commercial partner 4Cyte Pathology, transported to Rhythm’s clinical laboratory in Parkville, VIC, processed using the ColoSTAT assay, and results reported to the ordering clinician. The successful completion confirms that sample collection, logistics, assay processing, and result reporting all function effectively within routine clinical settings, validating that ColoSTAT can integrate into existing pathology workflows as a scalable testing service.
The validated operational pathway comprises:
- Blood sample collection at participating clinical sites
- Sample transport to Rhythm’s Parkville laboratory
- Processing using the ColoSTAT assay
- Result delivery to ordering clinicians
- Direct invoicing to participating practices
With infrastructure and logistics confirmed, Rhythm can now expand test volumes through primary care physicians and the ColoSTAT Access Program. Five participating sites across Victoria and New South Wales had already been onboarded ahead of this first test completion, providing immediate capacity for volume growth.
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What is ColoSTAT and why does early colorectal cancer detection matter?
ColoSTAT is a simple blood test that measures five specific protein biomarkers to detect the likelihood of colorectal cancer in symptomatic individuals. The test offers a less invasive alternative for patients showing symptoms associated with the disease, with blood-based diagnostics increasingly preferred over more invasive screening methods where clinically appropriate.
Global Disease Burden
Colorectal cancer is the second leading cause of cancer deaths globally. Early detection significantly improves treatment outcomes and can make the disease curable when caught at early stages.
The large addressable market, combined with the clinical need for accessible diagnostic options, supports long-term revenue potential for blood-based colorectal cancer tests. ColoSTAT is based on research from Australia’s CSIRO and benefits from international patent protection.
ColoSTAT Access Program provides structured pathway for adoption
Rhythm launched the ColoSTAT Access Program on 11 February 2026 to provide a structured entry point for clinicians to begin ordering tests while enabling the company to collect valuable clinical data. The programme allows participating physicians to order ColoSTAT for appropriate patients, supporting both clinical validation and commercial scale-up.
Five sites in Victoria and New South Wales were onboarded ahead of the first test completion, demonstrating physician interest and providing immediate infrastructure for volume expansion. The programme reduces execution risk by offering measurable adoption milestones through a controlled rollout approach.
| Milestone | Status | Significance |
|---|---|---|
| First commercial test sale | Completed 11 March 2026 | Validates end-to-end operational pathway |
| Access Program launch | Completed 11 February 2026 | Structures physician onboarding and data collection |
| Initial site onboarding | 5 sites (VIC and NSW) | Establishes immediate capacity for scale-up |
CEO outlines operational readiness for volume growth
Dr David Atkins, Managing Director and CEO, emphasised the operational significance of the milestone, noting the company’s readiness to expand testing volumes following successful pathway validation.
Dr David Atkins, Managing Director and CEO
“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.”
Rhythm will provide updates on commercial progress and adoption rates through regular quarterly reporting, offering investors measurable data points to assess commercialisation momentum.
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What investors should watch next
The first commercial sale represents the beginning of the commercialisation phase rather than an isolated event. Successful scale-up from validation to meaningful test volumes will be the critical proof point for the investment thesis as Rhythm transitions from a development-stage company to a revenue-generating diagnostics business.
Key metrics investors should monitor include:
- Test volume growth: Quarterly increases in ColoSTAT orders across participating sites
- Site expansion: Number of new clinicians and practices onboarded through the Access Program
- Revenue trajectory: Commercial testing revenue as operations scale beyond initial validation
- Geographic reach: Expansion beyond Victoria and New South Wales into additional Australian markets
The company has committed to providing commercial progress updates through its quarterly reporting cycle, offering transparency on adoption rates and operational performance. With the pathway validated and immediate scale-up capacity in place, the next reporting periods will reveal whether physician adoption and patient referrals support sustained volume growth.
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