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Performance of Novel Non-invasive Urine Assay UroSEEK in Cohorts of Equivocal Urine Cytology

Urine cytology is an essential element of the diagnostic workup of hematuria. A significant proportion of cases continue to be placed in the “atypical” or “suspicious” categories of the Paris system for urine cytology, posing difficulty in patient management. We report on the performance of our recently described urine-based assay “UroSEEK” in cases with equivocal diagnosis in patients who are investigated for bladder cancer. Urine samples were collected from two cohorts.

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

  1. Department of Pathology, The University of Alabama at Birmingham, Birmingham, AL 35233, USA
  2. Department of Pathology, The Johns Hopkins Hospital, Baltimore, MD 21231, USA
  3. The Ludwig Center for Cancer Genetics and Therapeutics, Baltimore, MD 21231, USA
  4. Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD 21231, USA
  5. Department of Pathology, Isfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, Isfahan, Iran

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