July 20, 2020 -- Liquid biopsy firm Nucleix touted results for its methylation-based Bladder EpiCheck urine test in two presentations at the 2020 European Association of Urology (EAU) virtual congress, being held July 17-26.
The first presentation, titled "Feasibility of the EpiCheck test in upper tract tumor: Interim analysis of a prospective trial," described the evaluation of 47 patients who had undergone ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018. Each patient had cytology and Bladder EpiCheck tests performed on voided urine and selective urine samples. Researchers found that 46% of patients were positive for UTUC as confirmed by endoscopic biopsy, half of which were high-grade. The interim analysis reported a significantly higher overall sensitivity of Bladder EpiCheck compared with cytology in voided urine (75% versus 39%). Bladder EpiCheck also displayed a higher sensitivity than cytology in high-grade UTUC (89% versus 64%) and a negative predictive value (NPV) of 95% versus 88% in voided urine.
The second presentation, "The diagnostic accuracy of Bladder EpiCheck in high-risk population," discussed the diagnostic accuracy of Bladder EpiCheck compared with cystoscopy and cytology (the current gold standard) in 167 consecutive patients with a history of or suspicion for high-risk bladder cancer. In patients with a history of high-grade non-muscle invasive bladder cancer (NMIBC) undergoing follow-up, the diagnostic accuracy of Bladder EpiCheck was higher than cytology and cystoscopy in terms of sensitivity (93.5%, 73.9%, and 58.1%, respectively) and NPV (96.4%, 87.5%, and 79.3%, respectively), researchers found.