Rhythm Opens NHS Pathway for ColoSTAT International Expansion

ColoSTAT Transfer Completed at Royal Surrey

Rhythm Biosciences Ltd (ASX:RHY) has cleared an important operational hurdle for its ColoSTAT blood-based bowel cancer test: an independent NHS laboratory in England can now run the assay using Rhythm’s equipment and reagents.

The Southern Hub research team at the Royal Surrey NHS Foundation Trust completed the technology transfer by testing company-supplied standards and controls in its own laboratory. That does not amount to clinical validation or regulatory approval, but it demonstrates that the test can be established and operated outside Rhythm’s own laboratory environment.

Analytical Evaluation Comes Before Clinical Evidence

The Hub is expected to move next into analytical evaluation, running ColoSTAT on patient clinical samples to assess whether the assay performs reliably and consistently in the new laboratory. If that stage succeeds, the program would proceed to a larger prospective clinical study intended to generate independent data on the test’s performance in an NHS laboratory setting.

Rhythm’s managing director and chief executive, Dr David Atkins, described the transfer as a “critical step” in taking ColoSTAT beyond a single laboratory. Professor Sally Benton, the Hub’s director, said the team was seeking ways to improve bowel cancer diagnostic pathways and looked forward to the next stages of the project.

International Opportunity Still Depends on Results

The Southern Hub’s role gives the program a credible external testing environment, particularly because its research has informed use of faecal immunochemical testing in screening and symptomatic pathways. The NHS Bowel Cancer Screening Programme issued about 8 million invitations in 2024-25, with uptake of approximately 65%, while the filing notes that many diagnoses still occur through the symptomatic pathway.

Rhythm says ColoSTAT could potentially support symptomatic patients unable or unwilling to complete stool-based testing, or help triage colonoscopy demand. It estimates the Australian opportunity at roughly 200,000 tests a year, while arguing that successful transfer to the UK laboratory strengthens its ability to pursue partners in other markets. Those ambitions remain conditional on analytical and clinical results, local regulatory approvals, reimbursement and suitable commercial arrangements.

The company has expressly warned that the timing, scope and outcome of the next phases are controlled by the Hub and are not within Rhythm’s control. There is no guarantee that either evaluation will succeed, that the NHS will adopt ColoSTAT, or that the work will produce a commercial agreement. The next meaningful signal will therefore be whether the analytical evaluation produces a basis for the prospective clinical study, rather than the transfer milestone alone.