Clinical Validation Study Supports a Non-Invasive Monitoring Approach Where MPS2-AS Accurately Guides the Need for Surveillance Biopsies
ANN ARBOR, Mich., May 5, 2026 /PRNewswire/ — Lynx Dx, a leader in innovative diagnostic solutions, announced today the validation of MyProstateScore 2.0 – Active Surveillance (MPS2-AS), the company’s latest breakthrough and the first non-invasive urine-based assay designed to guide biopsy decisions in men with Grade Group (GG) 1 prostate cancer. In a multisite external validation study published in The Journal of Urology, the test outperformed multiparametric MRI (mpMRI) in biopsy decision-making during active surveillance.
Unmet Need
Active surveillance is widely used for men with low-risk prostate cancer, but existing tools have important limitations and monitoring relies on repeated biopsies that burden patients and practices. MPS2-AS was developed as a more patient-friendly, non-invasive approach to help determine when a biopsy may or may not be necessary.
“Active surveillance works best when clinicians can reliably identify the patients who need a biopsy while sparing those who do not,” said Spencer Heaton, MD, CMO at Lynx Dx. “MPS2-AS is a promising non-invasive tool that helps reduce the burden of repeat biopsies, personalize monitoring, and support more confident decision-making for men living with low-risk prostate cancer.”
Validated Accuracy, Unprecedented Flexibility
MPS2-AS provides personalized risk estimates to help urologists and patients make more informed, individualized biopsy decisions during active surveillance. Published data in The Journal of Urology demonstrated that MPS2-AS outperformed mpMRI in a multisite validation study for detecting upgrading and could have avoided up to 64% of unnecessary biopsies. The test showed strong performance across clinically important endpoints, delivering 97% sensitivity and 99% NPV for GG≥3 upgrading, and 95% sensitivity and 92% NPV for GG≥2 upgrading.
About MyProstateScore 2.0 – Active Surveillance (MPS2-AS)
MPS2-AS is the first validated urine test designed to help guide biopsy decision-making for men with GG1 prostate cancer by providing personalized risk estimates for upgrading to both GG≥3 and GG≥2 disease, supporting more individualized, patient-friendly monitoring to help reduce unnecessary biopsies. MPS2-AS builds on the science behind the commercially available MyProstateScore 2.0, which supports biopsy decision-making before diagnosis. Similar to MPS2, MPS2-AS will fit a convenient at-home or in-office collection process, without the need for DRE or temperature-controlled shipping, expanding access and flexibility for men undergoing long-term surveillance.
Lynx Dx plans to make MPS2-AS available with Medicare coverage and will announce additional launch details at LynxDx.com/ActiveSurveillance.
About Lynx Dx
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, please visit LynxDx.com.
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SOURCE Lynx Dx
