ColoSTAT’s Commercial Rollout Begins Amid Uncertain Market Adoption
Rhythm Biosciences has taken a significant step toward commercialising its ColoSTAT blood test for colorectal cancer by enrolling the first physician in its Access Program, marking the transition from clinical trials to routine clinical use.
- First physician enrolled in ColoSTAT Access Program
- Initial free test allocation to establish clinical workflows
- Transition planned to paid commercial use upon validation
- Program capped at 20 participants to gather real-world data
- Supports future reimbursement and partnership strategies
A Milestone in Commercial Deployment
Rhythm Biosciences Ltd (ASX, RHY) has announced the enrolment of the first physician participant in its ColoSTAT Access Program, a pivotal moment in the company’s journey to bring its innovative blood-based colorectal cancer test into routine clinical practice. This milestone marks the transition of ColoSTAT from clinical development into structured commercial deployment, setting the stage for revenue generation and broader market adoption.
The ColoSTAT Access Program Explained
The Access Program is designed as a controlled pathway to introduce ColoSTAT safely and effectively into clinical use across Australia. Participating clinicians receive an initial allocation of ColoSTAT tests at no cost, allowing them to establish routine ordering and delivery processes. Once patient safety and clinical efficacy are confirmed, further tests will be supplied on standard commercial terms, with clinicians exercising independent judgement on continued use.
Participation is capped at 20 physicians, ensuring focused data collection and operational refinement. This approach enables Rhythm to gather real-world performance and utilisation data, which will underpin future reimbursement applications and support engagement with commercial partners and distributors.
Why This Matters for Colorectal Cancer Screening
Colorectal cancer remains the second leading cause of cancer death globally, with screening rates hindered by the invasive nature of current methods. ColoSTAT offers a simpler, blood-based alternative that could dramatically improve screening participation and enable earlier detection when treatment is most effective. The enrolment of the first physician participant signals early clinical acceptance and potential demand for this less invasive testing option.
Looking Ahead, Building Commercial Momentum
CEO and Managing Director Dr David Atkins emphasised the significance of this development, describing it as a "pivotal moment" that moves ColoSTAT from concept to commercial reality. The Access Program not only facilitates clinician adoption but also helps validate workflows and build the evidence base necessary for long-term market success.
With the first participant onboard, Rhythm plans to expand clinician involvement, generate further real-world data, and advance discussions with potential commercial partners. These steps are critical to establishing routine paid clinical use and scaling the test’s availability across healthcare providers.
Ultimately, the program lays the foundation for Rhythm Biosciences to transition from a research-focused entity to a commercial business, with ColoSTAT positioned as a promising tool in the fight against colorectal cancer.
Bottom Line?
Rhythm Biosciences’ first enrolment in the ColoSTAT Access Program signals the start of a crucial commercial journey toward routine clinical use and revenue growth.
Questions in the middle?
- How quickly will Rhythm expand physician participation beyond the initial enrollee?
- What timelines are anticipated for transitioning clinicians to paid commercial use?
- When might Rhythm secure reimbursement agreements or commercial partnerships?
