IBCN 2017: Bladder Cancer Pipeline- Clinical results of methylation-based multi-marker urine assay for monitoring

Lisbon, Portugal (UroToday.com) H. Bart Grossman from MD Anderson, Houston, TX presented a urine based assay to detect bladder cancer. Methylated genes, coding and non-coding, are expressed differently among cancer versus non-cancer patients. Bladder epicheck is a methylation-base multimarker urine assay using real time PCR, 15 DNA methylation markers which generates an EpiScore between 0 to 100 with score 60+ is a positive test. Urine needs to be refrigerated with 10cc or more of urine needed. The bladder EpiCheck CE multicenter study in 440 patients among 5 centers in Europe and Israel compared EpiCheck to cystoscopy with pathologic confirmation for positive or suspicious cystoscopies, and urine cytology. Sensitivity and specificity was 68% and 92%, respectively. Data form one of the centers had sensitivity and specificity of 90% and 83%, respectively. The negative and positive predictive values were 95% and 54%, respectively. However, positive predictive values are highly dependent on prevalence and specificity. The EpiCheck score may provide additional prognostic information regarding pathology, however, further validation according to clinical stage are needed prior to extrapolating these results.

Speaker(s): H. Bart Grossman from MD Anderson, Houston, TX

Written by: Stephen B. Williams, M.D., Associate Professor, Division of Urology, The University of Texas Medical Branch, Galveston, TX. and Ashish M. Kamat, M.D. Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX., at the International Bladder Cancer Network - October 21, 2017- Lisbon, Portugal