We’re pleased to confirm that the AUSSIE study has now been published in BJU International¹. The Australian study provides important new evidence that Cxbladder Triage Plus, a genomic test combining mRNA and DNA biomarkers, performs consistently across different patient populations and health systems, and further strengthens the clinical case for usage in the risk stratification of patients presenting with haematuria.

The study – the second peer reviewed clinical validation of Triage Plus and the first in an Australian population – reproduces the performance seen in the DRIVE study² and gives Australian clinicians and hospitals local peer-reviewed evidence supporting use of the test to help rule out urothelial cancer and defer an invasive cystoscopy and unnecessary imaging in patients with a low probability of disease.

The AUSSIE study enrolled 691 evaluable patients presenting with visible (gross) or non-visible (micro) haematuria across four Australian hospital urology clinics between September 2023 and August 2025:

• The test-negative rate (anticipated rule-out rate) was 74%. This highlights the potential economic value of Triage Plus for health providers, as a higher test negative rate creates greater opportunity for health systems to avoid unnecessary cystoscopies and their associated costs.
• The study analysed microhaematuria and gross haematuria patients separately with test-negative rates of 81% in microhaematuria (NPV 100%) and 70% in gross haematuria (NPV 98%).
• Within the microhaematuria population, test-negative rates were 100% in low-risk patients (NPV 100%), 89% in intermediate-risk patients (NPV 100%), and 76% in high-risk patients (NPV 99%). These results provide a clear demonstration of the utility of Triage Plus across the spectrum of haematuria risk.
• NPV remained at or above 99% across all microhaematuria risk categories, while the proportion of patients testing negative appropriately declined as underlying disease risk increased.

Read the study published in BJU International.

To discuss the findings, local availability, and how Triage Plus can support a risk stratified haematuria pathway, please contact us.

¹ Buhariwalla, V., Sethi, K., Vela, I., Hayne, D., Atchia, Z., de Lange, M., Lough, T., White, A. and Ranasinghe, W. (2026), Validation of Cxbladder Triage Plus in Australian patients with haematuria: the AUSSIE study. BJU Int. https://doi.org/10.1111/bju.70504

² Savage et al. (2026). Diagnostic performance of Cxbladder Triage Plus for the identification and stratification of patients at risk for urothelial carcinoma: The multicenter, prospective, observational DRIVE study. Urologic oncology, 44(1), 65.e13–65.e20. https://doi.org/10.1016/j.urolonc.2025.10.008