Rhythm Biosciences (ASX:RHY) has entered its commercialisation era, announcing the first physician enrollment in its ColoSTAT Access Program.
This milestone marks the company’s decisive shift from a research-heavy entity to a revenue-generating medical technology firm.
The program, currently capped at 20 select participants across Australia, serves as the primary vehicle for establishing clinical ordering workflows and gathering the "real-world" performance data essential for securing future government reimbursement.
To streamline initial adoption, Rhythm is providing the first wave of ColoSTAT tests at no cost, allowing clinicians to integrate the blood-based colorectal cancer test into their diagnostic suites.
The strategic rollout is underpinned by a robust manufacturing partnership with Quansys Biosciences, whose ISO 13485-certified facilities ensure the scalable production of reagent kits.
This follows a rigorous regulatory period, including the recent ISO 15189:2022 accreditation and a NATA assessment conducted in late January.