Exosomal RNA-Based Urine Liquid Biopsy Test Detects High-Grade Prostate Cancer With 97.5% Accuracy Prior to Initial Biopsy; Initial Positive Clinical Study Results Published; Novel Test Has Potential to Stem Tide of Unnecessary Initial Prostate Biopsies

On Monday, September 21, 2015, Exosome Diagnostics, Inc., a Cambridge, Massachusetts-based developer of revolutionary, biofluid-based molecular diagnostics, announced the publication of positive data from its initial clinical study of ExoIntelliScore™ Prostate (previously referred to as EXO 106), the first-catch-urine-based, three-gene-signature liquid biopsy test that does not require a digital rectal exam (DRE) or prostate massage before sample collection showing that the test results can predict high-grade prostate cancer (Gleason score ≥ 7) with 97.5 percent accuracy prior to initial biopsy. The paper in which the results are published is titled “A Molecular Signature of PCA3 and ERG Exosomal RNA from Non-DRE Urine Is Predictive of Initial Prostate Biopsy Result.” It was published online on September 8, 2015 in Prostate Cancer and Prostatic Diseases, a peer-reviewed journal of the Nature Publishing Group. Distinct from all other predictive tests on the market or in clinical development for prostate cancer, ExoIntelliScore Prostate is the first assay to give urologists and their patients molecular insights about prostate cancer using exosomal RNA (exoRNA). The test involves patients giving a simple, first-catch urine sample without having to first undergo a digital rectal exam (DRE). ExoIntelliScore™ Prostate is poised to drive a new prognostic paradigm in which the aggressiveness of prostate cancer can be predicted completely non-invasively from genetic-based information ahead of initial prostate biopsy. For men demonstrating a low-risk for aggressive disease using the assay, urologists may determine that an initial prostate biopsy is not warranted.
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