ExoDx Prostate Non-Invasive Test May Eliminate Unnecessary Prostate Biopsies, Study Says

ExoDx Prostate Non-Invasive Test May Eliminate Unnecessary Prostate Biopsies, Study Says
Exosome Diagnostics revealed positive clinical results evaluating its urine-based prostate cancer liquid biopsy test called ExoDx Prostate (IntelliScore). The study, “A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy,” published in JAMA Oncology, indicates the novel test could eliminate the need for tissue biopsies, supporting the value of investing in research targeting Exosomal RNA for diagnostic and patient screening applications. Exosome, who first presented the results at the 2015 American Urological Association (AUA) Annual Meeting, plans to launch the RNA-based test in the second quarter of 2016. In most developed countries, there is a tendency for overdiagnosis and overtreatment of low-grade (indolent) prostate cancer, which has become a significant health issue. Prostate-Specific Antigen (PSA) testing has low specificity, often resulting in false negative and false positive results and not distinguishing between high-grade and low-grade cancer, which usually does not require aggressive treatment. As such, there is a need for noninvasive, easy to administer, diagnostic assays to help assess if invasive biopsies are indeed necessary. In fact, over 75 percent of prostate biopsies end up being either benign or from low-grade cancers. Exome diagnostics developed the ExoDx Prostate (IntelliScore), a clinically validated, non-digital rectal exam urine-based liquid biopsy test that predicts the presence of high-grade (Gleason score of 7 or greater) prostate cancer for men age 50 and older with a PSA 2 to 10 mg/mL presenting for an initial bio
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