Related Experiment Video
Updated: Jun 23, 2026
06:12
Evaluation of the Efficacy of the H. pylori Protein HP-NAP as a Therapeutic Tool for Treatment of Bladder Cancer in an Orthotopic Murine Model
Published on: May 29, 2015
7.2K
mRNA-Based Urine Test Performance in High and Very-High Risk Non-Muscle-Invasive Bladder Cancer Patients Undergoing
Alberto Macchi1, Martina Bruniera1, Sebastiano Nazzani1
1Urologic Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Clinical Genitourinary Cancer
|April 8, 2025
Summary
The Xpert Monitor BC test shows high accuracy in detecting non-muscle-invasive bladder cancer recurrence. This biomarker test may offer a reliable, less invasive follow-up option for high-risk patients.
Area of Science:
- Uro-oncology
- Molecular diagnostics
- Cancer biomarkers
Background:
- Non-muscle-invasive bladder cancer (NMIBC) requires rigorous follow-up using cystoscopy (UCS) and voided urinary cytology (vUC) due to high recurrence and progression rates.
- The Xpert Monitor BC test, detecting 5 mRNAs in urine, is a novel biomarker proposed to reduce invasiveness and costs associated with NMIBC follow-up.
Purpose of the Study:
- To evaluate the reliability of the Xpert Monitor BC test as a standalone diagnostic procedure for detecting tumor recurrence in high-risk (HR) or very high-risk (VHR) NMIBC patients.
- To assess the early detection capabilities of Xpert Monitor BC during patient follow-up.
Main Methods:
- Prospective enrollment of 80 HR or VHR NMIBC patients between September 2022 and July 2023.
- Xpert Monitor BC testing on voided urine samples prior to cystoscopy; comparison of its performance (NPV, PPV, SE, SP) with voided urinary cytology (vUC), cystoscopy (UCS), and histology.
- Inclusion of both naïve and previously treated patients, excluding those with known upper urinary tract urothelial carcinoma (UTUC).
Main Results:
- In 76 evaluable patients, Xpert Monitor BC demonstrated a Negative Predictive Value (NPV) of 95.3% and Sensitivity (SE) of 90.5%.
- The test showed a Positive Predictive Value (PPV) of 57.6% and Specificity (SP) of 74.5%.
- Xpert Monitor BC detected recurrence in 3 patients with negative cystoscopy, suggesting potential for early detection of persistent/recurrent disease.
Conclusions:
- The study confirms the high NPV and SE of Xpert Monitor BC in HR and VHR NMIBC patients.
- Apparent false positive results warrant further investigation as they may indicate persistent or recurrent disease.
- Findings support the implementation of Xpert Monitor BC for improved cancer detection and suggest exploring its use as a single-test follow-up procedure.
