The first consisted of patients who presented with hematuria or lower urinary tract symptoms (early detection cohort) and the second of patients that are in follow-up for prior bladder cancer (surveillance cohort). Urine samples were analyzed for mutations in 11 genes and aneuploidy. In the early detection setting, we found high sensitivity and specificity (96% and 88%, respectively) and a strong negative predictive value of 99%. The assay performance was less robust in the surveillance cohort (sensitivity of 74%, specificity of 72%, and negative predictive value of 53%).
UroSEEK demonstrated a notable lead time to cancer diagnosis. Seven cases in the early detection cohort and 71 surveillance cases were detected at least 6 months prior to clinical diagnosis. Our results suggest a potential role for UroSEEK assay in guiding management of patients with atypical urine cytology if confirmed in future prospective trials.
Maria Del Carmen Rodriguez Pena1,2 & Simeon U. Springer3,4 & Diana Taheri2,5 & Lu Li3,4 & Aline C. Tregnago2 & Marie-Lisa Eich1,2 & Isam-Eldin A. Eltoum1 & Christopher J. VandenBussche2 & Nickolas Papadopoulos3,4 & Kenneth W. Kinzler3,4 & Bert Vogelstein3,4 & George J. Netto1,2
- Department of Pathology, The University of Alabama at Birmingham, Birmingham, AL 35233, USA
- Department of Pathology, The Johns Hopkins Hospital, Baltimore, MD 21231, USA
- The Ludwig Center for Cancer Genetics and Therapeutics, Baltimore, MD 21231, USA
- Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD 21231, USA
- Department of Pathology, Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
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