LAUSR

PURPOSE This is the first report of the development and performance of a platform that interrogates small non-coding RNAs (sncRNA) isolated from urinary exosomes (the miR Sentinel™ Tests): the Sentinel™ PCa Test, that classifies patients with prostate cancer from subjects with no evidence of prostate cancer, the miR Sentinel™ CS Test, that stratifies prostate cancer patients between those with low risk prostate cancer (GG1) from those with intermediate and high risk disease (GG2-5), and the miR Sentinel™ HG Test, that stratifies prostate cancer patients between those with low- and favorable intermediate-risk prostate cancer (GG1 or GG2) versus those with high risk (GG3-5) disease. METHOD sncRNAs were extracted from urinary exosomes of 235 participants and interrogated on miR 4.0 microarrays. Using proprietary Selection and Classification Algorithms, informative sncRNAs were selected to customize an interrogation OpenArray™ platform that forms the basis of the Tests. The Tests were validated using a case-control sample of 1436 subjects. RESULTS The performance of the miR Sentinel™ PCa Test demonstrated sensitivity = 94% and specificity = 92%. The Sentinel™ CS Test demonstrated a sensitivity = 93% and specificity = 90% for prediction of the presence of GG≥2 cancer, and the Sentinel™ HG Test demonstrated a sensitivity = 94% and specificity = 96% for the prediction of the presence of GG≥3 cancer. CONCLUSIONS The Sentinel™ PCa, CS and HG Tests, demonstrated high levels of sensitivity and specificity, highlighting the utility of interrogation of urinary exosomal sncRNAs for non-invasively diagnosing and classifying prostate cancer with high precision.