Analytical Validation of MyProstateScore 2.0.

Area of Science:

• Biomarker discovery and validation
• Urine-based diagnostics
• Prostate cancer research

Background:

• Prostate cancer (PCa) is a significant cause of male cancer mortality.
• Early detection of PCa is critical for improving patient outcomes.
• MyProstateScore 2.0 (MPS2) is a novel urine test designed to identify clinically significant PCa and reduce unnecessary biopsies.

Purpose of the Study:

• To evaluate the analytical performance of the MPS2 test.
• To assess MPS2 performance using both post-digital rectal exam (DRE) and non-DRE urine samples.
• To validate the reproducibility, precision, and detection limits of MPS2 analytes.

Main Methods:

• Assessed reproducibility, precision, and detection limits of 18 MPS2 analytes.
• Evaluated linear range, upper and lower limits of quantification (ULOQ/LLOQ), and potential interfering substances.
• Determined MPS2 score reproducibility in clinical urine samples (post-DRE and non-DRE).

Main Results:

• MPS2 analytes showed high linearity (R² ≥ 0.975) and efficient PCR (97-105%).
• Limits of detection (LOD) were 40-160 copies/reaction; ULOQ was 10^6-10^7 copies/reaction.
• Precision was high (≤0.5 Crt standard deviation), with whole blood being the only interfering substance. MPS2 score reproducibility was consistent across sample types.

Conclusions:

• Analytical validation confirms MPS2 is a robust and reliable tool for detecting clinically significant PCa biomarkers.
• The test demonstrates consistent performance regardless of urine sample type (post-DRE or non-DRE).
• Findings support the clinical utility of MPS2 as a non-invasive diagnostic method for prostate cancer.