Analytical Validation of MyProstateScore 2.0

Prostate cancer (PCa) remains the most common cancer and the second leading cause of cancer-related deaths among men in the United States. Early detection is critical, yet routine prostate-specific antigen (PSA) screening has shown limited benefits, often leading to unnecessary biopsies. MyProstateScore 2.0 (MPS2), a novel urinary 18-biomarker test, aims to improve the detection of clinically significant prostate cancer (csPCa) while minimizing the risk of unnecessary procedures. This study aims to validate the analytical performance of MPS2, including analytical detection limits, reproducibility, and robustness across various potential interfering substances. The limit of detection (LoD) and lower limit of quantitation (LLOQ) for the 18 MPS2 biomarkers ranged from 40 to 160 copies/reaction and 80 to 320 copies/reaction, respectively. The upper limit of quantitation (ULOQ) was determined to be up to 10^7 copies/reaction for most analytes. The linear amplification of MPS2 biomarker amplification was confirmed between the defined LLOQ and ULOQ. Eleven of 12 potential interfering substances tested had minimal impact on the assay. The exception was whole blood, which delayed biomarker detection. In conclusion, MPS2 exhibits robust analytical performance, with reliable detection and quantitation limits. This validation supports the clinical use of MPS2 for accurately predicting clinically-significant PCa, potentially reducing unnecessary biopsies and associated complications.