A microRNA biomarker panel for the non-invasive detection of bladder cancer

// Virginia Urquidi 1 , Mandy Netherton 2 , Evan Gomes-Giacoia 2 , Daniel J. Serie 3 , Jeanette Eckel-Passow 4 , Charles J. Rosser 1, 5 , Steve Goodison 1, 3, 6 1 Nonagen Bioscience Corporation, Jacksonville, FL, USA 2 Cancer Research Institute, MD Anderson Cancer Center, Orlando, FL, USA 3 Department of Health Sciences Research, Mayo Clinic, Jacksonville, FL USA 4 Department of Health Sciences Research, Mayo Clinic, Rochester, MN USA 5 University of Hawaii Cancer Center, Honolulu, HI USA 6 Department of Urology, Mayo Clinic, Jacksonville, FL USA Correspondence to: Steve Goodison, email: goodison.steven@mayo.edu Keywords: diagnostic biomarkers, bladder cancer, microRNA, multiplex, urinalysis Received: August 15, 2016      Accepted: November 08, 2016      Published: November 16, 2016 ABSTRACT The development of accurate, non-invasive urinary assays for bladder cancer would greatly facilitate the detection and management of a disease that has a high rate of recurrence and progression. In this study, we employed a discovery and validation strategy to identify microRNA signatures that can perform as a non-invasive bladder cancer diagnostic assay. Expression profiling of 754 human microRNAs (TaqMan low density arrays) was performed on naturally voided urine samples from a cohort of 85 subjects of known bladder disease status (27 with active BCa). A panel of 46 microRNAs significantly associated with bladder cancer were subsequently monitored in an independent cohort of 121 subjects (61 with active BCa) using quantitative real-time PCR (RT-PCR). Multivariable modeling identified a 25-target diagnostic signature that predicted the presence of BCa with an estimated sensitivity of 87% at a specificity of 100% (AUC 0.982). With additional validation, the monitoring of a urinary microRNA biomarker panel could facilitate the non-invasive evaluation of patients under investigation for BCa.