URINE BIOMARKER COHORTS, GENE EXPRESSION SIGNATURES, AND METHODS OF USE THEREOF

摘要

The present invention relates generally to the field of biomarker analysis, particularly determining gene expression signatures from urine samples. The disclosure provides compositions, kits and methods for diagnosing a prostate disorder such as prostate cancer in a male subject.

主权项

1. A method for the diagnosis, prognosis, monitoring or therapy selection for prostate cancer in a subject in need thereof, the method comprising the steps of:
a. obtaining a random urine sample from a subject; b. extracting one or more mRNAs from the sample; c. detecting the level of mRNA expression of PCA3 and ERG; d. normalizing the level of mRNA expression of PCA3 and ERG to SPDEF; e. computing an output value for the normalized mRNA expression levels of PCA3 and ERG using the formula:(log2max(1,ERGcopies)SPDEFcopies+log2max(1,PCA3copies)SPDEFcopies+16.92)*1.83togenerateanEXO106Score;  and f. comparing the EXO106 Score to a predetermined cutoff value that was determined using an ROC curve generated based on a combination of PCA3 and ERG to distinguish a subject at a high risk for prostate cancer from a subject with a low risk for prostate cancer.