Rhythm Biosciences has widened access to its ColoSTAT blood test, lifted quarterly revenue 64% and advanced reimbursement and NHS evaluation work. The progress sits alongside A$1.803 million in cash and an estimated 1.22 quarters of funding at the current operating burn.
- ColoSTAT test volumes rose 56% quarter on quarter, with 20% of requesting physicians repeat users
- 4Cyte collection network passed 100 eastern Australian sites and MedicalDirector ordering went live
- Health economic model estimated A$4.50 in public hospital costs avoided for every A$1 spent on testing
- NHS England laboratory completed technology transfer and is preparing to test patient samples
- Cash fell to A$1.803 million after A$1.474 million of operating cash outflow, covering 1.22 quarters
ColoSTAT adoption improves while funding remains tight
Rhythm Biosciences Ltd (ASX:RHY) made visible progress turning ColoSTAT® into a usable commercial service during the September quarter, but its cash position leaves little room for execution slippage. Quarterly test volumes rose 56% from the June quarter, revenue increased 64% to A$33,567, and the company ended September with A$1.803 million in cash.
The access infrastructure is now broader. Doctors using MedicalDirector have been able to order ColoSTAT directly from their practice software since 1 August, while 4Cyte Pathology’s collection network passed 100 sites across the eastern states, up from 78 at the end of March. Rhythm said about 20% of requesting physicians were repeat users during the quarter, an early indicator of recurring demand, although the filing does not provide the underlying test count.
Health economic case moves towards Medicare application
Rhythm also completed an independent health economic study intended to support a potential application to the Medical Services Advisory Committee for Medicare reimbursement. The model estimated that every A$1 spent on ColoSTAT could avoid about A$4.50 in public hospital costs. That is a modelled healthcare-system benefit, not evidence of realised savings or an approval of public funding; Rhythm still needs to engage with MSAC and develop its supporting submission.
The work builds on the ColoSTAT economic model that had earlier estimated potential annual public hospital savings, but the next test for the thesis is whether the evidence can translate into reimbursement and sustained clinical use. ColoSTAT also completed its notification into the TGA In-House IVD Notification Database for testing at Rhythm’s NATA-accredited Melbourne laboratory.
NHS evaluation reaches patient-testing stage
In England, technology transfer to the Southern Hub Laboratory at the Royal Surrey NHS Foundation Trust is complete. The laboratory can now run ColoSTAT independently, and the second stage of the evaluation is due to begin with patient samples. The milestone demonstrates that testing capability can be established outside Rhythm’s own laboratory, while the clinical results and any subsequent NHS adoption remain unresolved. It follows the first NHS laboratory transfer completed earlier in the year.
geneType portfolio expands beyond colorectal cancer
Rhythm is broadening its second platform as it works on risk assessment products. Its new geneType lung cancer risk test, developed and tested using data from about 500,000 UK Biobank participants, lifted reported accuracy from an AUC of 0.70 for age and smoking history alone to 0.86 when genetic and other risk factors were added. The company said the test identified 42% more lung cancer cases as eligible for screening than current Australian criteria, including some lighter smokers. Those findings are planned for independent peer review before the test moves into production.
The company also completed the first phase of an external review of US payment and reimbursement opportunities for geneType. Rhythm plans to seek initial feedback from a Medicare Administrative Contractor on whether existing CPT codes could apply and whether claims would be paid. In Australia, September was described as geneType’s strongest sales month, helped by higher volumes from existing customers and new productive accounts.
A 1.22-quarter runway puts execution under pressure
Operating cash outflow was A$1.474 million for the quarter, leaving estimated funding of 1.22 quarters at the reported burn rate and no unused finance facilities. That makes the FY26 cash runway warning more immediate even as commercial activity improves. Rhythm expects to lodge its FY26 research and development tax incentive claim in the coming weeks and says a refund of more than A$1 million is expected before the end of calendar 2026, but neither the timing nor receipt of that money is guaranteed.
For the December quarter, the practical milestones are the planned launch of Best Practice ordering, expansion towards up to 150 4Cyte collection centres, initial MSAC engagement, NHS patient-sample testing and the R&D tax claim. The question is whether those steps can convert access into enough testing revenue before the company must secure additional funding.
Bottom Line?
Rhythm has removed several access barriers, but the commercial rollout now has to produce faster cash support or the expected R&D refund and further funding will become central to the story.
Questions in the middle?
- Will the move into Best Practice ordering translate into materially higher ColoSTAT volumes and repeat use?
- What will NHS patient-sample testing show, and will it lead to a larger clinical or commercial evaluation?
- Can the expected R&D tax refund and future funding arrive before the reported 1.22-quarter cash cover is exhausted?