Rhythm Initiates Commercialisation of ColoSTAT

Open PDF
Stock RHYTHM Biosciences Ltd (RHY.ASX)
Release Time 12 Dec 2025, 9:26 a.m.
Price Sensitive Yes
 Rhythm Initiates Commercialisation of ColoSTAT
Key Points
  • Rhythm has commenced commercialisation of ColoSTAT following updated ISO15189:2022 accreditation
  • ColoSTAT will be offered as a blood-based diagnostic alternative for symptomatic individuals where stool-based testing is unsuitable
  • Commercialisation will begin with the ColoSTAT Access Program to support clinician experience and generate real-world data
Full Summary

Rhythm Biosciences Ltd (ASX:RHY) has announced the initiation of commercialisation activities for its flagship blood-based colorectal cancer (CRC) test, ColoSTAT. This follows the company's recently updated ISO15189:2022 accreditation, marking a major milestone in the transition to the first market launch of ColoSTAT. ColoSTAT will initially be offered for use in individuals who exhibit symptoms consistent with CRC, particularly where stool-based testing (the FIT test) is unsuitable or not preferred. This provides clinicians with an alternative pathway during periods of watchful waiting or in circumstances where stool-based screening cannot be completed. Commercialisation will begin with the ColoSTAT Access Program, which will include selected clinical leaders who will be supported by Rhythm to offer ColoSTAT to symptomatic individuals. This initiative is designed to support clinician experience with the test, generate additional real-world data, and further strengthen the existing evidence base as Rhythm prepares for broader market penetration. Consistent with Rhythm's commitment to quality and regulatory compliance, the company will proceed with a variation to scope assessment with the National Association of Testing Authorities (NATA) scheduled for January 23rd, 2026. Successful completion of this assessment would formally establish ColoSTAT as an accredited laboratory service, supporting clinician confidence and commercial scalability.