LynxDx, a developer of diagnostic solutions, is introducing MyProstateScore 2.0 (MPS2), a non-invasive, data-driven, urine prostate cancer screening test that aims to provide highly accurate, stratified risk assessment insights to guide clinical decisions for patients with elevated prostate-specific antigen (PSA) or abnormal digital rectal exam (DRE) findings.

Based on foundational work conducted by research scientists at the University of Michigan, MPS2 offers physicians and patients an accurate risk assessment to inform the decision whether to proceed with a prostate biopsy. This test enables physicians to improve the accuracy of prostate cancer screening compared to PSA alone.

“MyProstateScore 2.0 is a highly accurate, non-invasive post-DRE urine test capable of assessing with precise 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,” says Spencer Heaton, MD, MBA, chief medical and commercial officer of LynxDx. “Our goal is to offer the highest accuracy in the market through stratified intuitive results, avoid unnecessary testing and provide an improved patient experience.”

The survival rate of prostate cancer can be 100% if diagnosed early and contained within the prostate. To support this important public health effort, LynxDx originally developed MyProstateScore—the only test in the market capable of detecting the presence of the T2:ERG gene fusion, which is directly linked to prostate cancer. The MPS2 combines the specificity of the T2:ERG gene fusion with a supporting 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 next generation accuracy: 95% negative predictive value (NPV) for biopsy naive patients and 99% NPV for patients with a prior negative biopsy. The test is enhanced by patient-specific clinical factors, which offers a result that reflects a patient’s unique history. This level of personalization aims to provide a highly accurate lens into each patient’s individual risk of clinically significant cancer.

“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,” Heaton says. “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.”