Exosome Diagnostics’ Second Prospective Validation Study of Its Urine/Exosome-Based Prostate Cancer Liquid Biopsy Test (EPI) Highlighted at American Urological Association Annual Meeting Press Briefing

Exosome Diagnostics’ novel urine-based prostate cancer liquid biopsy biomarker test, ExoDx™ Prostate(IntelliScore) or EPI, was selected from among 3,000 abstracts for presentation at the Press Sessions during the American Urological Association (AUA) annual meeting. This elite group of abstracts undergoes a rigorous review and selection process to ensure the abstract is not only newsworthy, but also scientifically sound and ready for presentation to the general public. The study findings in over 500 men were to be presented by the study’s Lead Investigator, James McKiernan, MD, John K. Lattimer Professor and Chair, Department of Urology at New York-Presbyterian Hospital/Columbia University, during the AUA’s Press Session on Friday May 18, 2018. EPI is designed to reduce the number of unnecessary initial prostate biopsies in men 50 years of age or older, with a PSA (Prostate Specific Antigen) value between 2-10 ng/ml. The PSA blood test lacks specificity as a screening test for prostate cancer and does not discriminate between high- and low-grade cancer. The EPI urine liquid biopsy genomic test has been previously validated (JAMA Oncology 2016) as a “follow-on” test after PSA that identifies men at high risk of high-grade aggressive prostate cancer on prostate biopsy. This second prospective Validation Study, two years later, confirms the diagnostic value of the test in a contemporary population. Up to 2 million prostate biopsies are performed annually in the United States and Europe, and it is estimated that more than 75 percent of these biopsies are unnecessary because the patient has benign or low-grade/indolent prostate cancer. Use of the EPI test reduces the number of these unnecessary biopsies.
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