A test with added DNA markers to better risk stratify microhematuria patients

Cxbladder Triage Plus is a next generation Cxbladder test that employs a novel combination of mRNA and DNA biomarkers to enhance risk stratification, reducing unnecessary cystoscopies in microhematuria patients with a low probability of urothelial cancer, while prioritizing those who need immediate care.

With the publication of LCD DL4030378 in May, we expect that Triage Plus will be covered by Medicare for the risk stratification of appropriately consulted intermediate risk patients. We’re now pleased to offer the test to all our US customers. This includes streamlined access via our clinician customer portal.

Cxbladder Triage Plus provides the following benefits:

• Delivers significant improvement in NPV, Sensitivity, PPV and Specificity over our the established Cxbladder Triage and Detect tests.
• Increases the rate of UC rule out in patients with a low probability of disease, deferring those that who do not stand to benefit from an invasive cystoscopy.
• Enables the identification and prioritization of high-risk patients with high specificity and PPV (98% specificity and 75% PPV when higher 0.54 cut point on test report is used).
• Requires a urine sample only. No additional patient factors are required.
• Provides the option of in-home sampling, improving access, and reducing the burden on travel restricted patients.

With analytical and clinical validation shown in published studies^1,2, notably last year’s DRIVE publication in the Journal of Urologic Oncology, Triage Plus builds on the performance of Cxbladder Triage, a test now included in the AUA/SUFU Microhematuria Guideline³, supported with "Grade A" evidence from the STRATA randomized controlled trial⁴.

To discuss the use of Cxbladder Triage Plus in your practice, please email us at [email protected], or call us at 855-292-5237 to learn more.

¹ Harvey et al. (2025) Analytical Validation of the Cxbladder® Triage Plus Assay for Risk Stratification of Hematuria Patients for Urothelial Carcinoma. Diagnostics. 2025; 15(14):1739. https://doi.org/10.3390/diagnostics15141739.
² Savage et al. (2025) 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, S1078-1439(25)00405-3
³ Barocas DA, Lotan Y, Matulewicz RS, Raman JD, Westerman ME, Kirkby E, Pak L, Souter L. Updates to Microhematuria: AUA/SUFU Guideline (2025). J Urol. 0(0). doi: 10.1097/JU.0000000000004490.
⁴ Lotan et al. (2024) A Multicenter Prospective Randomized Controlled Trial Comparing Cxbladder Triage to Cystoscopy in Patients With Microhematuria. The Safe Testing of Risk for Asymptomatic Microhematuria Trial. The Journal of Urology Vol 212(1) 41-51.