Analytical Validation of MyProstateScore 2.0-Active Surveillance: A Urinary-Based Clinical RT-PCR Prostate Cancer...

Area of Science:

• Urology
• Biomarker Discovery
• Molecular Diagnostics

Background:

• Active surveillance (AS) for low-risk prostate cancer aims to prevent overtreatment but relies on invasive repeat biopsies.
• Current surveillance methods lack non-invasive tools to accurately predict disease progression.
• MyProstateScore 2.0-Active Surveillance (MPS2-AS) is a urine-based test designed to predict Grade Group (GG) progression in men on AS.

Purpose of the Study:

• To analytically validate the reproducibility and robustness of the MPS2-AS test.
• To assess analyte detection and risk score calculation across critical laboratory variables.
• To confirm the reliability of MPS2-AS for clinical implementation in prostate cancer management.

Main Methods:

• Analytical precision and reproducibility of MPS2-AS were evaluated using pooled urine samples.
• Ten RNA biomarkers were quantified via RT-PCR to calculate MPS2-AS GG1-2 and GG1-3 risk scores.
• Variability was assessed across different days, runs, qPCR instruments, and OpenArray chip lots using hierarchical ANOVA.

Main Results:

• MPS2-AS analyte measurements showed high precision (coefficients of variation [CV] ≤ 4.01%) within the laboratory.
• Reproducibility across instruments and chip lots demonstrated robust analyte quantification (CVs ≤ 4.57% and ≤ 4.10%).
• Risk score calculations were reproducible (CVs ≤ 10.69% for GG1-2 and ≤ 7.20% for GG1-3) with no systematic bias.

Conclusions:

• MPS2-AS exhibits strong analytical precision and reproducibility for urinary biomarker quantification and risk score generation.
• The test's reliability supports its clinical laboratory implementation for prostate cancer active surveillance.
• MPS2-AS offers a non-invasive tool to aid biopsy decisions for men with Grade Group 1 prostate cancer on AS.