On Septembeer 7, 2016, Exosome Diagnostics, Inc. announced the launch of its ExoDx® Prostate(IntelliScore) test (EPI) through the company’s CLIA-certified laboratory in Cambridge, Massachusetts. EPI is a laboratory-developed test designed to provide clinicians and patients with information that will improve the prostate biopsy decision-making process. EPI is the first test using specific genetic information captured from a simple urine sample to provide physicians with a score to help evaluate their patient’s risk for high-grade, potentially more aggressive prostate cancer. In the United States each year, approximately one million prostate biopsies are performed with up to 80 percent of the results indicating no cancer, or a low-grade cancer that could instead be monitored under a watchful waiting or active surveillance program. The EPI test was designed to reduce the number of unnecessary prostate biopsies and the associated overtreatment of low-grade disease. Complications associated with unnecessary prostate tissue biopsies range from discomfort and temporary incontinence or impotence, to hospitalization for serious infections in three to four percent of patients. “Prostate cancer is really a spectrum of disease. Not all patients have the same type of tumor or the same grade of disease,” stated Peter Carroll M.D., Chair of Urology at the University of California, San Francisco and an investigator in the EPI clinical validation trial.
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