Rhythm Biosciences (ASX:RHY) has initiated the commercial deployment of its ColoSTAT test by enrolling the first physician in its capped Access Program, signalling a significant step towards paid clinical use and real-world data generation for market access.
The Access Program is presently capped at 20 participants across Australia.
To facilitate the establishment of ordering and delivery workflows, initial ColoSTAT tests are being provided at no cost to participating clinicians.
This milestone is pivotal for Rhythm, supporting its stated transition from a research and development (R&D) focus to a commercial, revenue-generating business model.
The program is specifically designed to generate real-world data, which will be crucial in supporting future reimbursement discussions and strengthening engagement with partners.
Manufacturing and Regulatory Readiness
The company previously secured a multi-year commercial manufacturing agreement with Quansys Biosciences for its ColoSTAT reagent kits.
This partnership ensures scalable production capacity.
Notably, Quansys Biosciences' manufacturing facilities are ISO13485-certified, underscoring a commitment to quality and regulatory compliance.
Prior updates from Rhythm Biosciences also highlighted an updated ISO15189:2022 accreditation and a planned NATA variation assessment for 23 January 2026, further bolstering regulatory readiness.
Financial and Strategic Context
Rhythm Biosciences' FY2025 annual report outlined a strategic shift towards revenue generation, following the December 2024 Genetype acquisition and progress on ColoSTAT Gen2.
The company also reported its first commercial geneType revenues in FY2025.
Recent capital raises, including an oversubscribed $3.75 million placement and an expected $1.6 million R&D tax rebate, are intended to provide funding for these commercialisation efforts.
Strategic partnerships with organisations such as Know Your Lemons Foundation and Memorial Sloan Kettering Cancer Center, alongside ongoing clinical validation, support the broader commercial strategy.
Outlook and Risks
The commencement of the ColoSTAT Access Program is a key step towards commercialization.
Success will depend on converting participants to paid utilization, scaling market access, and navigating execution risks related to regulatory approvals and adoption, while managing ongoing cash burn.
