A urine biomarker test ruled out bladder cancer in haematuria with a 99% negative predictive value

Design

Multicentre prospective observational diagnostic accuracy study

Population

691 Australian adults with visible or non-visible haematuria referred for cystoscopy

Primary outcome

Diagnostic accuracy of urine biomarker vs cystoscopy and histology

Effect

Sensitivity 89%, specificity 79%, PPV 27%, NPV 99%; 6 of 54 tumours missed

AUSSIE was a prospective observational study at four Australian sites (BJU International, 18 October 2026). Adults with visible or non-visible haematuria, no history of urothelial cancer and a cystoscopy referral gave a midstream urine sample for the Cxbladder Triage Plus assay before cystoscopy.

Of 691 patients with evaluable samples, 54 (7.8%) had a confirmed tumour. Against cystoscopy and histology, the test had sensitivity of 89%, specificity 79%, positive predictive value 27% and negative predictive value 99%; 74% of patients tested negative. Six tumours were missed: five low-grade Ta tumours and one T3b urachal adenocarcinoma. Compared with 2025 AUA risk stratification, positive predictive value was 3.3-fold higher.

A test with a very high negative predictive value could help prioritise cystoscopy, especially for lower-risk non-visible haematuria. The missed urachal adenocarcinoma is a reminder that a negative urine test does not replace imaging or clinical judgement, and guidelines still recommend cystoscopy for visible haematuria.

• Do not use a negative urine biomarker alone to skip cystoscopy in visible haematuria; guidelines have not changed.
• Consider urine biomarker triage, where available, to help prioritise lower-risk non-visible haematuria referrals.
• Remember that one in nine cancers was missed, mostly low-grade, but including one invasive tumour.
• Keep upper-tract imaging in the haematuria work-up regardless of urine test result.
• Indian availability and cost of this assay are not established; standard cystoscopy pathways apply.

Why it matters

Most patients referred with haematuria have no cancer, and a reliable rule-out test could shorten queues for those who do.

Don't overread it

This is an observational validation of a commercial test; it does not show that using it changes outcomes.

The statistics, in plain English

Negative predictive value depends on prevalence: with cancer in 7.8%, a 99% NPV means about 1 in 100 negatives had cancer. In a higher-risk population the NPV would be lower.

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