Imagine a world where detecting a potentially life-threatening condition like bladder cancer could be done with a simple, non-invasive test, saving patients from unnecessary procedures and anxiety. That’s exactly what the CxBladder Triage Plus Test promises to deliver, and a recent study has just validated its potential. But here’s where it gets even more intriguing: this test doesn’t just detect—it stratifies risk, pinpointing which patients with blood in their urine (hematuria) are at higher risk for urothelial carcinoma, a common type of bladder cancer.
Published in Urologic Oncology, the observational DRIVE study (NCT04943380) confirmed the clinical validity of the CxBladder Triage Plus Test. This diagnostic tool builds on its predecessor, the CxBladder Detect+ test, by analyzing the mRNA expression of five known biomarkers and six DNA SNPs from FGFR3 and TERT. These genetic markers help categorize patients into low-risk (below a 0.15 threshold) or intermediate- to high-risk (above 0.15) groups for urothelial carcinoma.
The DRIVE study focused on adult patients from Veterans Affairs clinics who presented with either visible blood in their urine (gross hematuria) or microscopic blood (microhematuria). Researchers compared the Triage Plus test’s performance against traditional methods like white light cystoscopy and the 2025 American Urological Association (AUA) risk stratification guidelines.
And this is the part most people miss: the Triage Plus test not only matched but often outperformed these conventional methods. Lead author Stephen J. Savage, MD, highlighted its superiority in a conversation with Urology Times®, stating, “These findings demonstrate the improved utility of the Cx Bladder Triage Plus test over other urine-based assays, including AUA risk stratification, when assessing risk for hematuria patients.” He added that the test’s validation in a diverse patient population, including over 30% African American patients, is particularly encouraging.
The study included 615 patients, with 278 having gross hematuria and 337 having microhematuria. Among them, 48 (7.8%) were diagnosed with urothelial carcinoma, including 35 high-grade or carcinoma in situ cases and 13 low-grade cases. In the overall cohort, the Triage Plus test demonstrated impressive metrics: a sensitivity of 94%, specificity of 77%, positive predictive value (PPV) of 26%, negative predictive value (NPV) of 99.3%, and a test-negative rate (TNR) of 71%.
But here’s where it gets controversial: while the test’s NPV suggests it’s highly effective at ruling out cancer, its PPV indicates that only about one in four positive results actually confirms the disease. This raises questions about potential overdiagnosis or unnecessary follow-ups. However, when compared to the 2025 AUA guidelines, which flagged 97.4% of patients for further evaluation with a PPV of just 8.0%, the Triage Plus test’s PPV of 26.3% represents a 3.3-fold improvement.
The study also explored using a higher threshold (0.54) for the Triage Plus test, which increased specificity to 95% but reduced sensitivity to 60%. This trade-off could be valuable in certain clinical scenarios, though further research is needed to determine optimal usage.
One of the most striking findings was the test’s ability to “rule out” 70.9% of patients from further evaluation, with 99.3% of these patients having normal cystoscopy results later on. It missed only three tumors—one high-grade and two low-grade—underscoring its potential to reduce unnecessary procedures while maintaining accuracy.
Here’s the kicker: despite its promise, the authors caution that more research is needed to validate the test in diverse patient populations and ensure its generalizability. Savage emphasized, “It will be important to see how the assay is utilized in the future and to ensure that, when adopted, there is minimal adverse impact.”
So, what do you think? Is the CxBladder Triage Plus Test a game-changer in bladder cancer diagnostics, or does its PPV leave room for skepticism? Share your thoughts in the comments below—we’d love to hear your perspective!
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