Lynx Dx Launches Ordering for At-Home Collection Version of MyProstateScore 2.0

Convenient test now available for ordering by physicians, eligible for Medicare reimbursement.

ANN ARBOR, Mich., Feb. 20, 2025— Lynx Dx, a leader in innovative diagnostic solutions, today announced the commercial launch of MyProstateScore 2.0 (MPS2) for at-home collection by patients. The test kit, ordered by a physician, is now available to patients and is eligible for Medicare reimbursement.

The launch follows research published in the Journal of Urology that found MPS2 delivers market-leading accuracy in predicting the risk of clinically significant prostate cancer even without conducting a digital rectal exam (DRE) before collecting a urine sample.

“Giving patients the option to take the test at home, without the need to schedule a visit to the doctor or have a DRE, adds convenience, removes stigma and broadens access to a powerful method of screening for a serious disease,” said Spencer Heaton, Chief Medical Officer at Lynx Dx. “MyProstateScore 2.0 offers more clarity about the need for a biopsy in a way that aligns seamlessly with modern clinical workflows.”

The study in Journal of Urology, found 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). While PSA testing remains the gold standard of prostate cancer screening, the test provides an incomplete picture and results in overutilization of prostate biopsies, three-quarters of which come back negative for clinically significant prostate cancer.

Physicians can now order MPS2 for patients to complete without a DRE, either in the office or at home. This flexibility makes MPS2 compatible with telehealth practices and enhances access for patients in underserved areas. The collected urine samples remain stable without temperature control or special packaging, ensuring reliable results and the ability to ship samples any day of the week.

“The accuracy and convenience of the MPS2 biomarker test, available for at-home or in-office use, has enabled me to confidently consider deferring initial or repeat prostate biopsies in men with elevated PSA levels,” said Jeffrey Bassett, MD, MPH, a board-certified urologist with Hoag in Newport Beach, Calif.

Physicians can order MPS2 test kits for delivery by contacting Lynx Dx’s Client Services team at 1-888-978-8677 or clientservices@lynxdx.com.

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.

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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