Rhythm Biosciences

Rhythm Biosciences enters 2026 with greater commercial momentum than at any point in its history, and Pitt Street Research considers this the year in which both ColoSTAT and GeneType begin to demonstrate meaningful commercial traction. The immediate priority for ColoSTAT is completing the NATA variation to scope assessment, which would formally add ColoSTAT to the company’s accredited laboratory services rather than offering it as a general laboratory service. This step would support broader clinician use and a more formal commercial rollout beyond the initial limited programs that commenced in December 2025. Looking further ahead, the company plans to resubmit to the TGA for formal ARTG inclusion as an In Vitro Diagnostic Medical Device, which would expand access to non-laboratory environments. The company is also in the early stages of international expansion: the NHS Southern Hub Research Team in the United Kingdom will evaluate ColoSTAT for suitability for general use during 2026, and the company is developing a lung cancer screening assay with pre-clinical data evaluation and assay prototype design expected to be completed during CY26. For GeneType, the company has committed to significant quarter-on-quarter revenue growth, including over 100 percent growth in Q1 of FY26. The sales pipeline is growing rapidly, underpinned by the four distribution and collaboration partnerships established in 2025. The GeneType test is currently priced at A$399 per risk test kit and is already generating revenue, establishing a commercial foundation that ColoSTAT has yet to match. The market opportunity backing both products is substantial. The Australian screening population for colorectal cancer at 7.4 million people aged 50 to 74, with 96.7 million in the same bracket in the United States and 20.8 million in the United Kingdom. For GeneType, the company targets a global market of 207 million Normal Active Risk Assessors and 69 million Higher Risk assessors. Even a 1 percent penetration of that combined addressable market would represent approximately 2.76 million patients. The underlying disease burden reinforces the opportunity. Colorectal cancer was estimated to have caused 1.9 million new cases and 900,000 deaths globally in 2022. These figures are projected to grow to 3.2 million cases and 1.6 million deaths annually by 2040 if current trends continue. Participation rates in Australia’s government-funded Faecal Immunochemical Test program remain at only 40 to 45 percent, largely due to the cumbersome and unpleasant nature of stool collection. Research has shown that blood tests are the preferred screening method for more than 83 percent of currently unscreened individuals, and at least one study found that uptake increased from 12.6 percent to 93.5 percent when a same-day blood test replaced the FIT as the offered screening option. This represents the core commercial case for ColoSTAT: a clinically validated blood test that addresses the primary reason why millions of people avoid bowel cancer screening.