Rhythm Biosciences (ASX:RHY) has commenced commercialisation of its flagship blood-based colorectal cancer test, ColoSTAT, following the update and renewal of its ISO15189:2022 laboratory accreditation.
The test will initially be offered as an alternative for symptomatic individuals where stool-based screening is unsuitable, unavailable, or not preferred, addressing a significant unmet clinical need.
Commercial rollout will begin through Rhythm's Melbourne-based certified laboratory under the ColoSTAT Access Program, which engages selected clinical leaders to offer the test, generate real-world data, and support broader market adoption.
The company plans a variation to scope assessment with the National Association of Testing Authorities in January 2026 to formally establish ColoSTAT as an accredited laboratory service, further bolstering clinician confidence and scalability.
Rhythm CEO Dr. David Atkins said the launch offers a welcome new option for Australians unable or unwilling to undergo current standard bowel cancer screening, while Chairman Gavin Fox-Smith highlighted the achievement as a key milestone in the company's commitment to delivering ColoSTAT to market by the end of 2025.
At the time of reporting, Rhythm Biosciences' share price was $0.11.