However, few studies have tested the diagnostic potential of EV analysis in humans. This pilot study suggests that urinary EVs have the potential to be used as a platform to non-invasively differentiate patients with prostate cancer with very good accuracy. Larger studies are needed to confirm the potential for clinical utility. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the paper and its Supporting Information files. This study was supported by Exosome Diagnostics, Inc. Exosomes and microvesicles are lipid bilayer vesicles usually 30β nm in diameter. During formation, exosomes and microvesicles collectively referred to herein as extracellular vesicles EVs encapsulate a portion of the parent cell cytoplasm including membrane proteins, cytosolic proteins [ 1 ] and nucleic acids chiefly RNA referred to herein as exoRNA [ 2 , 3 ].
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The EVs are then released from cells and may be harvested from biofluids including blood and urine. To date there have been few substantial studies to understand the potential diagnostic use of EVs. Prostate cancer represents the most common cancer in men and the second most common cause of cancer-related death in the United States [ 4 ]. Serum prostate specific antigen PSA is used as a biomarker for prostate cancer although this strategy has been criticized due to its low sensitivity and specificity [ 5 ].
This over-diagnosis and overtreatment results in decreased quality of life and increased healthcare costs, highlighting the urgent need for more sensitive and specific diagnostic strategies [ 7 , 8 ].
In , it was reported that prostate-related genes could be successfully detected in urinary EVs [ 9 ]. We have recently advanced methods to i rapidly isolate intact EVs removing reliance on ultracentrifugation and enabling adaptation to the clinical laboratory setting and ii obtain high integrity exoRNA important for reliable transcriptional analysis [ 10 , 11 ].
