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Updated: Oct 1, 2025

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Cell-Free DNA Integrity Analysis in Urine Samples
Published on: January 5, 2017
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Improved urine DNA methylation panel for early bladder cancer detection
Qixun Fang1,2, Xu Zhang3, Qing Nie1
1Yaneng Bioscience, Co., Ltd, Shenzhen, 518100, China.
BMC Cancer
|March 4, 2022
Summary
A new urine-based methylation panel (P3) shows high accuracy for detecting bladder cancer. This panel offers improved specificity and sensitivity compared to existing methods, aiding in early diagnosis.
Area of Science:
- Urology
- Oncology
- Molecular Diagnostics
Background:
- Bladder cancer diagnosis relies on invasive methods with limited accuracy.
- There is a need for non-invasive, sensitive, and specific diagnostic tools for bladder cancer.
Purpose of the Study:
- To develop and validate an improved urine-based methylation panel for bladder cancer detection.
- To enhance diagnostic accuracy and specificity for bladder cancer.
Main Methods:
- Reviewed existing methylation panels and selected 19 candidates.
- Utilized Reduced Representation Bisulfite Sequencing (RRBS) on 45 samples to refine panel markers.
- Developed a new panel (P3) using PCDH17, POU4F2, and PENK biomarkers.
- Validated the P3 panel using quantitative Methylation-Specific Polymerase Chain Reaction (qMSP) on independent cohorts (33 and 207 samples).
Main Results:
- The P3 panel demonstrated high performance: 100% specificity and 71% sensitivity with RRBS.
- With qMSP, the P3 panel achieved 100% specificity and 84% sensitivity in a balanced cohort.
- In a larger validation cohort (207 samples), the P3 panel with qMSP showed 97% specificity and 87% sensitivity.
Conclusions:
- The P3 methylation panel offers a promising, accurate, and sensitive non-invasive diagnostic tool for bladder cancer.
- This urine-based approach represents a significant improvement over current diagnostic methods for bladder cancer.

