Cxbladder® Triage Plus

Cxbladder Triage Plus is a next generation Cxbladder test that employs a novel combination of mRNA and DNA biomarkers to extend best in class performance.

Triage Plus enhances the risk stratification and rule out of urothelial cancer (UC) in patients presenting with haematuria, reducing unnecessary cystoscopies in patients with a low probability of disease, while prioritising those who need immediate care.

With analytical and clinical validation shown in published studies¹⁻⁴, Triage Plus builds on the performance of Cxbladder Triage, a test now included in the American Urological Association Microhaematuria Guideline³ supported with "Grade A" evidence from the STRATA randomised controlled trial.⁴

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. Advance online publication. https://doi.org/10.1016/j.urolonc.2025.10.008

³ Barocas et al. (2025) Updates to Microhematuria: AUA/SUFU Guideline (2025). The Journal of urology, 213(5), 547–557. https://doi.org/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.

• Delivers significant improvement in NPV, Sensitivity, PPV and Specificity over the original Cxbladder Triage test.

• Increases the rate of urothelial cancer 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 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).

• Simplifies practice workflow as a single test optimised for the evaluation of both gross and microhaematuria. Requires a urine sample only. No additional patient factors are required.

Urine in Cxbladder container

30–50 mL midstream urine collected into the Cxbladder collection tube (contains preservative). Do not use catheter samples.

Available through Codex Genetics as the authorised Pacific Edge distributor in Hong Kong. Please contact us for test kits, collection instructions, and ordering.

The Cxbladder Triage score ranges from 0.0 to 1.0.

LOW Probability (< 0.15): An NPV of 99.4% for scores <0.15. Low probability of UC.

INTERMEDIATE Probability (0.15 ≤ score < 0.54): A sensitivity of 93.6% and a specificity of 90.8% for scores ≥ 0.15 and < 0.54. Increased probability of UC.

HIGH Probability (≥ 0.54): A PPV of 74.6% for scores > 0.54 with a specificity of 98.2% in the validation cohort. High probability of UC.