Urine Prostate Cancer Screening Test Offers Best-In-Class Accuracy and Stratified Risk Assessment

S. men and still remains the second-leading cause of cancer death. However, the traditional testing method of monitoring prostate-specific antigen (PSA) is just one piece in a complicated puzzle. In order to arrive at the full picture for predictive decision making, physicians need to know why the PSA level is elevated, understand the individual’s risk level, and whether further testing is required. Now, a non-invasive, urine prostate cancer test offers a new level of simple, actionable, and data-driven decision making for both providers and patients.

LynxDx, Inc. (Ann Arbor, MI, USA) is introducing MyProstateScore 2.0 (MPS2), a non-invasive, data-driven, urine prostate cancer screening test that provides highly accurate, stratified risk assessment insights to guide clinical decisions for patients with elevated PSA or abnormal digital rectal exam (DRE) findings. Based on foundational work conducted by research scientists at the University of Michigan (Ann Arbor, MI, USA), MPS2 offers physicians and patients a highly accurate risk assessment to confidently inform the decision whether to proceed with a prostate biopsy. The revolutionary test is convenient, informative, and enables physicians to improve the accuracy of prostate cancer screening as compared to PSA alone.

LynxDx had originally developed MyProstateScore which is the only test in the market that is capable of detecting the presence of the T2:ERG gene fusion, which is directly linked to prostate cancer. The new MPS2 test now represents the next generation in risk testing by combining the specificity of the T2:ERG gene fusion with an array of 17 other genetic biomarkers that support the diagnosis of clinically significant prostate cancer. Using these 18 unique biomarkers, MPS2 assesses the risk of prostate cancer with optimized, cohort specific accuracy: 95% negative predictive value (NPV) for biopsy naive patients and 99% NPV for patients with a prior negative biopsy. For biopsy naive patients, MPS2 is a standalone biomarker test. For patients with a prior negative biopsy, relevant clinical factors specific to a patient are included in the algorithm. This level of personalization provides a highly accurate lens into each patient's individual risk of clinically significant cancer.

"MyProstateScore 2.0 is a highly accurate, non-invasive post-DRE urine test capable of assessing with accuracy a patient's individualized risk of having clinically significant prostate cancer. This insight enables providers and patients to determine the most appropriate next steps in the patient's care, as the path is unique for each person," explained Spencer Heaton, MD, MBA, Chief Medical and Commercial Officer of LynxDx. "By using MPS2, clinicians can more confidently inform their patients whether or not a clinically significant cancer is present, or if their elevated PSA result was due to other factors. This is critical in determining whether a biopsy is needed as a next step in the diagnostic process. MPS2 offers patients peace of mind and potentially life-saving early detection through a simple risk assessment test. Ultimately our goal is to apply evidence-based, personalized data to improve people's lives."

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LynxDx, Inc. 
University of Michigan