Urinary Analysis of <i>FGFR3</i> and <i>TERT</i> Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk Stratification
Yair Lotan, Jay D. Raman, Badrinath R. Konety, Siamak Daneshmand, Florian R. Schroeck, Shahrokh F. Shariat, Peter C. Black, Michel de Lange, Scott Asroff, Evan R. Goldfischer, Mitchell Efros, Kian Tai Chong, Eugene Huang, Hong Liang Chua, Qing Wu, Siying Yeow, Weida Lau, Jin Hua Yong, M Eng
Abstract
PURPOSE: genes, in addition to the current 5 mRNA biomarkers and clinical risk factors. MATERIALS AND METHODS: Two multicenter, prospective studies were undertaken in: (1) U.S. patients with gross hematuria aged ≥18 years and (2) Singaporean patients with gross hematuria or microhematuria aged >21 years. All patients provided a midstream urine sample and underwent cystoscopy. Samples were retrospectively analyzed using enhanced Cxbladder-Triage (risk stratifies patients), enhanced Cxbladder-Detect (risk stratifies patients and detects positive patients), and the combination enhanced Cxbladder-Triage × Cxbladder-Detect. RESULTS: < .001). CONCLUSIONS: This study in ethnically diverse patients with hematuria showed the analytical validity of the enhanced Cxbladder tests.