Results of Clinical Study Show Promise of First-in-Class, Exosome-Based, Predictive Liquid Biopsy Test to Address Unnecessary Surgical Biopsies, Over-Diagnosis, and Over-Treatment of Indolent Prostate Cancer

Exosome Diagnostics, Inc., a developer of revolutionary, biofluid-based molecular diagnostics, presented new positive data from a clinical study for the company’s novel, urine-based prostate cancer liquid biopsy, ExoIntelliScore™ Prostate (formally referred to as Exo106). The data demonstrated that ExoIntelliScore Prostate accurately predicted, in pre-radical prostatectomy (RP) urine samples of patients with prostate cancer, objective clinical features present in RP specimens and also provided initial improved discrimination of RP Gleason Score 4+3, a subset of patients at elevated risk for aggressive disease. These results add to a growing body of clinical validation evidence that show ExoIntelliScore Prostate’s unique ability to accurately, and completely non-invasively, identify high-grade prostate cancer. The results also suggest the potential for the first-in-class genetic-based assay to be utilized throughout the diagnostic paradigm, including prior to initial biopsy, as well as for sequential monitoring of disease progression in patients enrolled in active surveillance. The data were presented at a poster session entitled, “A Non-Invasive Urine Exosome Gene Expression Assay (ExoIntelliScore™ Prostate) Accurately Predicts Pathologic Stage and Grade in the Prostatectomy Specimen,” at the 18th European Cancer Congress (ECCO) – 40th European Society for Medical Oncology (ESMO) Annual Meeting in Vienna, Austria (September 25-29). Note that a link to a PDF of the complete poster is provided at the end of this article. “The current diagnostic landscape for prostate cancer is imprecise, setting off a cascade of events that starts with unnecessary and inaccurate biopsies, and leads to over-diagnosis and over-treatment of the disease with radical treatment choices, including prostatectomies,” said co-author James A.
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