# Urinary PCA3/MSMB RT-qPCR assay shows 82.63% sensitivity in clinical study

- Published: 2026-11-07 04:50 UTC
- Section: Life & Health › Medicine
- Tags: urinary PCA3 MSMB assay, prostate cancer noninvasive diagnosis, RT-qPCR urine test, prostate cancer biomarkers, non DRE urine sampling
- URL: https://realtech.media/news/rt-7b6fe117c11c12168da5b617_urinary_pca3_msmb/

**Researchers evaluated a novel RT-qPCR test on 643 patients, demonstrating that non-invasive urine sampling without prior rectal examination matches standard accuracy.**

![Urinary PCA3/MSMB RT-qPCR assay shows 82.63% sensitivity in clinical study](https://realtech.media/media/2026/11/f6a373ec66f4df04.jpg)
*İnformatic, Wikimedia Commons, CC BY-SA 3.0*

Researchers evaluated a novel noninvasive reverse transcription-quantitative polymerase chain reaction (RT-qPCR) assay for prostate cancer diagnosis across three prospective multicenter cohorts totaling 643 Chinese men, according to a study published in UroPrecision [1]. The test quantifies prostate cancer antigen 3 (PCA3) expression in urine using microseminoprotein-beta (MSMB) as a reference gene instead of the conventional kallikrein-related peptidase 3 (KLK3).

## Diagnostic performance

In the initial evaluation cohort of 176 participants, the PCA3/MSMB test demonstrated superior diagnostic performance compared to the traditional PCA3/KLK3 assay. The system achieved an area under the receiver operating characteristic curve (AUC) of 0.869 versus 0.830 for the conventional method (p = 0.0468) [1]. Sensitivity reached 82.1% compared to 79.0%, while specificity reached 77.8% compared to 74.1%.

Validation in the second cohort of 350 patients confirmed the test parameters [1]. The system demonstrated an overall sensitivity of 82.63% and a specificity of 77.50%, showing high precision and stability under clinical evaluation standards.

## Sample collection method

In the third cohort comprising 117 participants, the investigators compared diagnostic accuracy between first-morning urine samples collected without prior digital rectal examination (DRE) and conventional post-DRE samples [1]. The diagnostic performance showed no statistically significant difference, with an AUC of 0.859 for non-DRE samples compared to 0.850 for post-DRE samples (p = 0.6262).

The authors concluded that the urinary PCA3/MSMB RT-qPCR platform enables accurate prostate cancer detection while eliminating the requirement for digital rectal massage before sampling [1]. This protocol has the potential to simplify collection routines and reduce unnecessary prostate biopsies.

## Sources

1. [UroPrecision](https://doi.org/10.1002/uro2.70060)
2. [EurekAlert](https://www.eurekalert.org/news-releases/1150792)

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Source: RealTech, realtech.media — https://realtech.media/news/rt-7b6fe117c11c12168da5b617_urinary_pca3_msmb/