Lynx Dx Introduces At-Home Collection Option for MyProstateScore 2.0

Revolutionizing Prostate Cancer Risk Assessment with a More Patient-Centered Approach

ANN ARBOR, Mich., Feb. 03, 2025 /PRNewswire/ -- Lynx Dx, a leader in innovative diagnostic solutions, announced today that its pioneering MyProstateScore 2.0 (MPS2) will be made available for at-home sample collection, enabling broader accessibility and helping more men safely avoid biopsies. The news follows the study published in the Journal of Urology, which found that MPS2 delivers high accuracy in predicting clinically significant prostate cancer using urine collected without a preceding digital rectal exam (DRE). This advancement further establishes MPS2 as a transformative tool in prostate cancer screening, offering unparalleled diagnostic flexibility and patient convenience without compromising accuracy.

The at-home version of MPS2 is expected to be available for ordering in February.

Unmet Need
Prostate cancer remains a significant health challenge, being the second leading cause of cancer-related deaths in American men. Traditional screening methods often lead to excessive biopsies, overdiagnosis of low-grade cancer, and patient discomfort. Lynx Dx aims to address these challenges with the MPS2 test, which is designed to accurately assess the risk of clinically significant prostate cancer while reducing exposure to risks associated with biopsies.

"Lynx Dx is proud to offer a solution that provides men with a more convenient, accessible, and accurate option for prostate cancer screening," said Dr. Spencer Heaton, Chief Medical Officer at Lynx Dx. "By eliminating the need for a DRE, MPS2 now empowers patients to collect their samples in the comfort of their homes, a significant step forward in prostate cancer risk assessment and our commitment to patient-centered care."

Validated Accuracy, Unprecedented Flexibility
Published data from The Journal of Urology demonstrate the accuracy of MPS2 in predicting the risk of clinically significant prostate cancer using urine collected without the need for a DRE, paving the way for convenient at-home and telehealth applications. The study demonstrated that MPS2 significantly outperformed traditional prostate-specific antigen (PSA) testing by identifying up to 53% of men whose biopsy would be negative while maintaining 91–94% sensitivity for high-grade cancer (Grade Group ≥2).

Patients now have the flexibility to complete the MPS2 test without a DRE in-office or at home, ensuring compatibility with modern telehealth practices and improving access for individuals in remote or underserved areas. The collected urine samples are stable without temperature control or special packaging, ensuring reliable results. Because of this stability, patients can ship their samples any day of the week without worrying about degradation.

"The ability to collect MPS2 samples at home without requiring a digital rectal exam empowers patients and providers with a test that is both convenient and precise," said Dr. Ganesh S. Palapattu, MD, FACS, FRCS. "By enhancing patient comfort and optimizing clinical workflows, this approach aligns with the evolving needs of modern healthcare. Our findings show that this method maintains the high accuracy and efficiency of MPS2, which continues to set the standard for accurate, efficient prostate cancer risk assessment, exemplifying how innovation and accuracy can go hand in hand."

About MyProstateScore 2.0 (MPS2)
MPS2 is a urine test designed to predict the presence of clinically significant prostate cancer by analyzing expression of 18 unique gene transcripts, including the T2:ERG gene fusion, the most specific biomarker for prostate cancer. 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.

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 unparalleled customer experience. For more information about Lynx Dx and MyProstateScore 2.0, please visit www.lynxdx.com. 

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

Media contact
Chad Van Alstin
[email protected]
941-281-5821

SOURCE LynxDx