April 18, 2024

Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer

Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer

Lynx Dx’s Biomarker Test Offers Market-Leading Accuracy in Prostate Cancer Risk Assessment

ANN ARBOR, Mich., April 18, 2024– Lynx Dx, a leader in innovative diagnostic solutions, hailed new peer-reviewed research published today in the Journal of the American Medical Association (JAMA) Oncology that validates the efficacy of MyProstateScore 2.0 (MPS2), the company’s groundbreaking prostate cancer risk assessment test. The findings signify a major advancement in the ability to make highly accurate, comprehensive and personalized predictions by raising the performance standard for urine biomarker tests intended to detect clinically significant prostate cancer.

Unmet Need

Prostate cancer is the most common cancer and the second leading cause of cancer death in American men, affecting nearly one in eight. The prostate specific antigen (PSA) blood test has long been considered the gold standard for early detection of prostate cancer, but because PSA levels can be elevated for many unrelated reasons, it offers an incomplete picture. Further, more than 75% of men with an elevated PSA will have a biopsy negative for clinically significant cancer.

Clinical Validation

In the clinical validation of MPS2 published in JAMA Oncology, scientists evaluated whether MPS2 could improve prostate cancer screening outcomes relative to existing biomarkers.

Key findings from the paper include:

  • MPS2 was clinically validated separately in patients presenting for initial biopsy (i.e., biopsy naïve) and those presenting for a repeat biopsy (i.e., prior negative biopsy).
  • Use of the test would safely identify 42% to 51% of patients who would not have clinically significant prostate cancer found on biopsy, while maintaining high sensitivity for high-grade cancers.
  • The test was validated for use as a biomarker-only test or inclusive of optional clinical risk factors.
  • The test performed significantly better compared to existing biomarker tests.

The research was funded by the Michigan-Vanderbilt Early Detection Research Network Biomarker Characterization Center (grant U2C CA271854) and the Early Detection Research Network Data Management and Coordinating Center (EDRN) (grant U24 CA086368). Study analysis and validation occurred in the EDRN.

“The research findings confirm the role of MPS2 to guide a more informed decision about whether to proceed with a prostate biopsy – a decision that is notoriously difficult to get right,” said Lynx Dx Chief Medical Officer Spencer Heaton, MD, MBA. “Lynx Dx’s goal is to provide best-in-class diagnostic tests that enable urologists and patients to make confident decisions, while greatly improving the rate of life-saving early detection.”


MPS2 is a urine test designed to predict the presence of clinically significant prostate cancer by analyzing expression of 18 unique gene transcripts. The test optimizes diagnostic accuracy for both biopsy naïve patients and those with a prior negative biopsy. Additionally, it provides diagnostic flexibility with optional assessment of personalized risk factors known to influence the development of clinically significant prostate cancer.

Lynx Dx has an exclusive license from the University of Michigan to commercialize the groundbreaking science that is the foundation for MPS2.

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: “Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer,” JAMA Oncology. doi:10.1001/jamaoncol.2024.0455

About Lynx Dx

Using technology developed at the University of Michigan, Lynx Dx provides best-in-class diagnostic testing services to help people live healthy and productive lives. The company’s mission is to develop superior genomic tests where there is clear patient need. Lynx Dx produces tests with the highest degree of accuracy and efficiency combined with an unparalleled customer experience. For more information about Lynx Dx and MyProstateScore 2.0, please visit www.lynxdx.com.

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Stephanie Fraser