Development and prospective validation of a multitarget urine RNA assay for noninvasive detection of urothelial carcinoma

Accurate and noninvasive diagnosis is critical in the management of urothelial carcinoma (UC). This study develops and prospectively validates a multitarget urine RNA (mt-uRNA) test for noninvasive UC detection. The RNA panel, built using quantitative RT-PCR and support vector machine algorithms, achieved an area under the curve of 0.956 in the upgraded training set of 688 samples. In the prospective validation phase, urine samples from 752 patients in three Chinese medical centers were analyzed, and the test achieved an overall accuracy of 93.4%, with a sensitivity of 92.3% and specificity of 94.1%. This robustness was maintained across subgroups, demonstrating high sensitivity for carcinoma <i>in situ</i>, low-grade, and upper tract UC (83.3%, 89.9%, and 97.3%) and high accuracy in hematuria, residual and recurrent subpopulations (93.6%, 86.9%, and 92.7%). These findings underscore the mt-uRNA test's high diagnostic utility for noninvasive UC detection, offering a promising alternative/adjunct to endoscopy for hematuria investigations and surveillance.

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Publication Details

Journal
iScience
Published
2025-11-20
DOI
https://doi.org/10.1016/j.isci.2025.114154
Primary Topic
Bladder and Urothelial Cancer Treatments
Type
article
Field-Weighted Citation Impact
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article

Development and prospective validation of a multitarget urine RNA assay for noninvasive detection of urothelial carcinoma

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iScience
Bladder and Urothelial Cancer Treatments
article

Development and prospective validation of a multitarget urine RNA assay for noninvasive detection of urothelial carcinoma

Banggao Huang, Xiaolong Qi, Gonghui Li, Jinying Chen, Dingwei Xue, Qijun Wo, Shuixin Lou, Zhihui Xu, Yixin Wo, Lifeng Ding, Zujie Mao, Shuai Wang, Qi Zhang, Feng Liu, Hua Xu, Luo Zheng-zhi, Dingwei Ye, Jie Yuan, Qinghua Xu, Shibin Zhu
article en

Abstract

Accurate and noninvasive diagnosis is critical in the management of urothelial carcinoma (UC). This study develops and prospectively validates a multitarget urine RNA (mt-uRNA) test for noninvasive UC detection. The RNA panel, built using quantitative RT-PCR and support vector machine algorithms, achieved an area under the curve of 0.956 in the upgraded training set of 688 samples. In the prospective validation phase, urine samples from 752 patients in three Chinese medical centers were analyzed, and the test achieved an overall accuracy of 93.4%, with a sensitivity of 92.3% and specificity of 94.1%. This robustness was maintained across subgroups, demonstrating high sensitivity for carcinoma <i>in situ</i>, low-grade, and upper tract UC (83.3%, 89.9%, and 97.3%) and high accuracy in hematuria, residual and recurrent subpopulations (93.6%, 86.9%, and 92.7%). These findings underscore the mt-uRNA test's high diagnostic utility for noninvasive UC detection, offering a promising alternative/adjunct to endoscopy for hematuria investigations and surveillance.

iScienceVol. 28(12)
Shanghai Medical College of Fudan University (CN), Sir Run Run Shaw Hospital (CN), Fudan University Shanghai Cancer Center (CN), ID Genomics (United States) (US), Hangzhou Medical College (CN)
Openalex Percentile: Top 46%
Bladder and Urothelial Cancer Treatments
DOIOpen Access PDFOpenAlex
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