Diagnostic performance of Cxbladder Triage Plus for the identification and stratification of patients at risk for urothelial carcinoma: The multicenter, prospective, observational DRIVE study.

INTRODUCTION

Cxbladder Triage Plus provides risk stratification for the presence or absence of urothelial carcinoma (UC) in patients presenting with hematuria. Triage Plus is a multimodal urinary biomarker test that detects 5 UC-associated mRNAs and 6 DNA single-nucleotide variants from fibroblast growth factor receptor 3 and telomerase reverse transcriptase genes. The aim of this study was to provide external validation of the diagnostic performance of Triage Plus for evaluation of UC in a veterans affairs (VA) population with hematuria.

METHODS

The multicenter, prospective, observational DRIVE study enrolled adults (≥18 years) from VA clinics presenting with gross hematuria or microhematuria. Midstream urine samples were tested with Triage Plus and with Cxbladder Triage and Detect. The primary objective was external clinical validation of the diagnostic performance of Triage Plus versus white light cystoscopy and pathological confirmation as the standard for primary UC diagnosis.

RESULTS

Of 615 patients with hematuria (278 with gross hematuria, 337 with microhematuria), 48 (7.8%) had histologically confirmed UC and 587 (95.4%) had available Triage Plus results. Compared with cystoscopy, Triage Plus had sensitivity of 94% (95% confidence interval 83%-99%), specificity of 77% (73%-80%), positive predictive value (PPV) of 26% (20%-34%), negative predictive value (NPV) of 99.3% (97.3%-99.9%), and a test-negative rate (TNR) of 71% (67%-75%). Triage Plus had higher specificity, PPV, and TNR than Triage, and higher sensitivity and NPV than Detect.

CONCLUSIONS

Triage Plus demonstrated clinical validity in veteran patients with hematuria, with improved sensitivity and specificity compared with earlier assays.