Key Highlights

  • A Southern Hub research laboratory within the Royal Surrey NHS Foundation Trust has completed the technology transfer of ColoSTAT.
  • The milestone completes the first phase of the independent evaluation program announced in December 2025.
  • Analytical evaluation is the next step, with a prospective clinical study planned if that phase is completed successfully.
  • Rhythm said the completed technology transfer supports its laboratory-partnership strategy for potential expansion into international markets.

Rhythm Biosciences (ASX:RHY) has reached the first milestone in the independent assessment of its ColoSTAT blood-based bowel cancer test in England. The Southern Hub Research Team, based at the Royal Surrey NHS Foundation Trust and part of the NHS Berkshire and Surrey Pathology Services network, has completed the technology transfer of the assay. The Hub team can now operate ColoSTAT in its own laboratory using Rhythm’s system and reagents, clearing the first stage of a broader evaluation process.

Technology Transfer Phase Reaches Completion

The first phase required Rhythm to transfer a complete ColoSTAT system and associated reagents to the Hub laboratory. The laboratory team then tested company-supplied standards and controls containing reference samples with known results. That work has now been completed. According to Rhythm, technology transfer is required when a diagnostic assay is intended to be operated outside the developer’s own laboratory environment. Completion of this stage demonstrates that the assay can be established and operated by an external laboratory team, an important element of Rhythm’s laboratory-partnership commercialisation model.

Analytical Evaluation Becomes the Next Step

The program now moves to analytical evaluation. During this phase, the Southern Hub team is expected to run ColoSTAT on patient clinical samples within its own laboratory to assess whether the assay performs reliably and consistently in that setting. If the analytical phase meets the required criteria, the program would move to a larger prospective clinical study. That study is intended to generate independent data on ColoSTAT’s ability to detect bowel cancer when operated within an NHS laboratory environment.

The company has also highlighted the uncertainties surrounding the process. The timing, scope and outcome of both the analytical evaluation and any subsequent clinical study are determined by the Hub rather than Rhythm. The company stated that there is no certainty that either phase will be successful, that the NHS will adopt ColoSTAT, or that the assessment will lead to a commercial arrangement. These conditions leave further validation work ahead before the program can progress beyond its current evaluation stage.

Southern Hub Brings Bowel Cancer Diagnostic Experience

The Southern Hub has research experience relating to how the faecal immunochemical test, or FIT, is used across bowel cancer screening and symptomatic pathways. Rhythm said this provides relevant scientific capability for assessing biomarkers used by ColoSTAT. The NHS Bowel Cancer Screening Programme offers stool-based testing every two years to people aged 50 to 74. According to the announcement, approximately eight million screening invitations were issued in 2024-25, with uptake of around 65%.

Rhythm is positioning ColoSTAT primarily as a blood-based test for people experiencing symptoms associated with colorectal cancer. The test measures five protein biomarkers that indicate the likelihood of colorectal cancer. The company has identified potential applications in the symptomatic pathway, including for people unable or unwilling to complete stool-based testing and potentially as a triage tool to help prioritise colonoscopy capacity.

International Laboratory Partnerships Remain a Focus

Rhythm has already launched ColoSTAT in Australia as a clinical service. The company estimates the domestic opportunity at approximately 200,000 tests annually, based on its estimate of the proportion of Australian colonoscopies undertaken for diagnostic purposes. Following the first transfer of the assay to an independent laboratory, Rhythm said it is better positioned to pursue additional laboratory partnerships in other geographies. Any expansion would remain subject to local regulatory approvals, reimbursement arrangements and suitable commercial agreements.

Key Insights

The latest announcement marks completion of the technology-transfer stage of ColoSTAT’s NHS laboratory evaluation rather than completion of clinical validation or adoption. The assay can now be run independently by the Southern Hub team, allowing the program to move into analytical evaluation. The next material milestones will depend on whether the assay performs consistently on clinical samples and whether the Hub subsequently progresses to the planned prospective clinical study.