Lynx Dx, a leader in innovative diagnostic solutions, 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.
