February 3, 2025

MyProstateScore 2.0 Clinical Validation Using Non-DRE Urine

MyProstateScore 2.0 Clinical Validation Using Non-DRE Urine

Traditional urine-based prostate cancer tests often require a digital rectal exam (DRE) to enhance biomarker release, which can cause discomfort and limit access to testing. The non-DRE version of MyProstateScore 2.0 (MPS2) solves these problems. New peer-reviewed research published in the Journal of Urology validates the use of MPS2 with a non-DRE testing approach to provide a convenient, highly accurate option to reduce the need for imaging or biopsy in men with elevated PSA.

In the clinical validation, scientists evaluated whether MPS2 could enhance the detection of clinically significant prostate cancer using non-DRE urine compared to traditional PSA testing and risk calculators.

Key findings from the paper include:​

  • The study validated the use of first-catch, non-DRE urine, making the MPS2 test more patient-friendly, especially for telehealth consultations or at-home testing, while maintaining strong clinical performance.
  • The use of MPS2 on non-DRE urine would safely identify up to 53% of patients who would not have clinically significant prostate cancer found on biopsy, while maintaining high sensitivity for high-grade cancers.​
  • The non-DRE test application was validated for use as a biomarker-only test or inclusive of optional clinical risk factors.​
  • The test performed significantly better compared to serum PSA and the Prostate Cancer Prevention Trial (PCPT) risk calculator.​

The paper’s first authors are Jeffrey J. Tosoian, M.D., M.P.H., who is now at Vanderbilt University, and Yuping Zhang, Ph.D., and Lanbo Xiao, Ph.D., at U-M. Additional authors are Cassie Xie; Nathan L. Samora, M.D.; Yashar S. Niknafs, Ph.D.; Zoey Chopra; Javed Siddiqui; Heng Zheng, M.D.; Grace Herron; Neil Vaishampayan; Hunter S. Robinson, M.D.; Kumaran Arivoli; Bruce J. Trock, Ph.D.; Ashley E. Ross, M.D., Ph.D.; Todd M. Morgan, M.D.; Ganesh S. Palapattu, M.D.; Simpa S. Salami, M.D., M.P.H.; Lakshmi P. Kunju, M.D.; Scott A. Tomlins, M.D., Ph.D.; Lori J. Sokoll, Ph.D.; Daniel W. Chan, Ph.D.; Sudhir Srivastava, Ph.D.; Ziding Feng, Ph.D.; Martin G. Sanda, M.D.; Yingye Zheng, Ph.D.

Funding for this work is from the Michigan-Vanderbilt Early Detection Research Network Biomarker Characterization Center and Data Management and Coordinating Center, which are through the National Cancer Institute grants U2C CA271854 and U24 CA086368. Additional funding is from NCI grants P50 CA186786, R35 CA231996, U24 CA115102, U01 CA113913; Prostate Cancer Foundation; Howard Hughes Medical Institute; and the American Cancer Society. Any mention of specific products, services, companies, or organizations does not imply endorsement by these organizations.

Disclosures: Chinnaiyan serves on the advisory boards of Tempus, Lynx Dx, Ascentage Pharmaceuticals, Medsyn therapeutics, Esanik and RAAPTA therapeutics. Tomlins is an equity holder and chief medical officer of Strata Oncology. Lynx Dx has obtained an exclusive license from the University of Michigan to commercialize MPS2 and the TMPRSS2-ERG gene fusion. Tosoian and Chinnaiyan are equity holders and scientific advisers to Lynx Dx. Siddiqui, Zhang, Xiao and Niknafs have served as scientific advisers to Lynx Dx.

Paper cited: “Clinical Validation of MyProstateScore 2.0 Testing Using First-Catch, Non-DRE Urine,” Journal of Urology. DOI: 10.1097/JU.0000000000004421