Validation of Cxbladder Triage Plus in Australian patients with haematuria: the AUSSIE study

Objectives To assess the clinical validity of Cxbladder Triage Plus (Pacific Edge Ltd., Dunedin, New Zealand), a non‐invasive urinary biomarker assay, for urothelial carcinoma (UC) risk stratification compared with standard‐of‐care evaluation (cystoscopy) in patients presenting with visible or non‐visible haematuria (VH or NVH) in routine practice in Australia. Patients and Methods A multicentre, prospective, observational study (AUSSIE; Australian and New Zealand Clinical Trial Registry identifier: ACTRN12622001127796) enrolled adults (aged ≥18 years) presenting with VH or NVH, no UC history and a cystoscopy referral between September 2023 and August 2025 across four Australian clinical sites. Midstream urine samples were tested with Cxbladder Triage Plus prior to cystoscopy. The primary outcome was diagnostic performance of Cxbladder Triage Plus (sensitivity, specificity, positive predictive value [PPV], negative PV [NPV], and test‐negative rate [TNR]) vs white light cystoscopy and histopathological UC confirmation. Results Of 691 patients with evaluable samples (424 with VH, 267 with NVH), 54 (7.8%) had histopathology‐confirmed tumours (44 with VH, 10 with NVH). Compared with cystoscopy, Cxbladder Triage Plus had sensitivity of 89%, specificity 79%, PPV 27%, NPV 99%, and TNR 74%. Six tumours were not detected (five low‐grade Ta, one T3b urachal adenocarcinoma). Compared with 2025 American Urological Association risk stratification criteria, Cxbladder Triage Plus provided a 3.3‐fold increase in PPV. Conclusion These findings provide clinical validation of Cxbladder Triage Plus for UC risk stratification in Australian patients presenting with VH or NVH in routine clinical practice.