Urine Liquid Biopsy Test Detects High-Grade Prostate Cancer

New screening methods that can add predictive diagnostic value for aggressive prostate cancer (PCa) are needed to reduce unnecessary biopsies for patients with non-aggressive PCa.

A first-catch urine-based, three-gene signature liquid biopsy test that does not require a digital rectal exam or prostate massage before sample collection can predict high-grade prostate cancer with extreme accuracy prior to initial biopsy.


The assay, which is distinct from all other predictive tests on the market or in clinical development for prostate cancer, gives urologists and their patients’ molecular insights about prostate cancer using exosomal ribonucleic acid RNA (exoRNA). The test involves patients giving a simple, first-catch urine sample without having to first undergo a digital rectal exam (DRE). For men demonstrating a low-risk for aggressive disease using the assay, urologists may determine that an initial prostate biopsy is not warranted. The test is particularly useful in for men 50 years of age and older with a Prostate-specific antigen (PSA) of 2 to 10 mg/mL

The assay, known as ExoIntelliScore Prostate (Exosome Diagnostics, Inc., Cambridge, MA, USA) is poised to drive a new prognostic paradigm in which the aggressiveness of prostate cancer can be predicted completely noninvasively from genetic-based information ahead of initial prostate biopsy. As a result, ExoIntelliScore Prostate has the potential to help stem the tide of unnecessary biopsies that occur today given the current void of accurate pre-initial biopsy prognostic information. Exosomal RNA-based urine liquid biopsy test detects high-grade prostate cancer with 97.5% accuracy prior to initial biopsy.

Vince O'Neill, MD, chief medical officer at Exosome Diagnostics, said, “There currently is a lack of diagnostic tools to discriminate between high-grade and low-grade prostate cancer. As a result, most men with elevated PSA levels are moved immediately to tissue biopsy, even though many have low-grade or no prostate cancer. ExoIntelliScore Prostate offers a new tool to accurately predict the aggressiveness of prostate cancer prior to initial biopsy based on real-time, comprehensive genetic information derived from exosomal RNA.”

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Exosome Diagnostics, Inc.