Prospective DRIVE Study Demonstrates Strong Diagnostic Performance of CxBladder Triage Plus in Hematuria Evaluation

The CxBladder Triage Plus DRIVE (Detection and Risk Stratification In Veterans Presenting with Hematuria) study (NCT04943380) demonstrated high diagnostic accuracy for detecting urothelial carcinoma in patients presenting with hematuria, achieving 94% sensitivity and a 99% negative predictive value in a real-world veteran cohort. These findings support its integration into clinical pathways to more effectively stratify risk and potentially reduce unnecessary cystoscopies in patients at low risk.

CxBladder Triage Plus Test

• Manufacturer: Pacific Edge Cancer Diagnostics
• Test Type: Non-invasive genomic
• Sample Requirement: Midstream urine
• Detection Method: Urinary biomarker assessment, including mRNA expression of 5 bladder-cancer-associated genes [CDK1, MDK, IGFBP5, HOXA13, & CXCR2] and 6 DNA Single-Nucleotide Polymorphisms (SNPs) from FGFR3 and TERT
  • mRNA expression and quantification via reverse transcription
  • DNA-SNPs expression via droplet-digital PCR (ddPCR)

DRIVE Study Design & Population

• Study Objective: Validation of the diagnostic performance and clinical utility of the CxBladder Triage Plus test versus cytoscopy (standard of care) and pathological confirmation in patients with hematuria
• Participants: 615 multicultural adult Veterans (278 gross hematuria & 337 microhematuria)
  • 48 histologically confirmed urothelial carcinoma
    • 35 high-grade/carcinoma in situ tumors
    • 13 low-grade tumors
• Method: Multicenter, prospective, observational study
• Readout Categories: low-, intermediate-, or high-risk for urothelial carcinoma
  • low-risk = below 0.15 threshold
  • Intermediate-/high-risk = above 0.15 threshold

Primary Outcomes

• The CxBladder Triage Plus test excluded 70.9% of patients from further evaluation, and 99.3% of those subsequently underwent a normal cystoscopic examination.
  • Sensitivity: 94% (95% CI, 83% to 99%)
  • Specificity: 77% (95% CI: 73, 80)
  • Positive Predictive Value (PPV): 26% (95% CI, 20% to 34%)
  • Negative Predictive Value (NPV): 99.3% (95% CI, 97.3% to 99.9%)
  • Test-Negative Rate (TNR): 71% (95% CI, 67% to 75%).

Clinical Implications

• ✔ More Efficient Risk Stratification: Safely identifies low-risk patients who may avoid immediate cystoscopy
• ✔ Reduced Invasive Procedures: High NPV allows many patients to defer cystoscopy without compromising safety
• ✔ Improved Resource Utilization: Lowers procedural burden and improves workflow in busy urology practices
• ✔ Increased Predictive Accuracy: Higher PPV helps target patients who truly require further evaluation
• ✔ Supports Personalized Decision-Making: Enables tailored diagnostic plans based on individual risk

Limitations

• Broader Population Validation Needed: Additional studies in diverse patient populations are required to improve the test’s generalizability.

Sources:

“Efficacy and Utility of Cxbladder Tests in Hematuria Patients.” Clinicaltrials.gov, 2 Feb. 2024, clinicaltrials.gov/study/NCT04943380?term=AREA%5BBasicSearch%5D(cxbladder)&rank=2. Accessed 1 Dec. 2025.

Savage, Stephen J, et al. “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, 2025, pp. S1078-1439(25)004053, pubmed.ncbi.nlm.nih.gov/41176469/, https://doi.org/10.1016/j.urolonc.2025.10.008. Accessed 1 Dec. 2025.

Clarke, Hannah. “Study Validates Diagnostic Performance of CxBladder Triage plus Test.” Urology Times, MJH Life Sciences, 18 Nov. 2025, www.urologytimes.com/view/study-validates-diagnostic-performance-of-cxbladder-triage-plus-test. Accessed 1 Dec. 2025.