Analytical Validation of Cxbladder^® Detect, Triage, and Monitor: Assays for Detection and Management of Urothelial Carcinoma.

ABSTRACT: Background: Cxbladder^® assays are reverse transcription-quantitative polymerase chain reaction (RT-qPCR) tests incorporating five genetic biomarkers (CDK1, MDK, IGFBP5, HOXA13, and CXCR2) to provide risk stratification for urothelial carcinoma (UC) in patients with hematuria or undergoing surveillance for recurrent disease. This study evaluated the analytical validity of the Cxbladder Detect, Triage, and Monitor assays. Methods: Pre-specified acceptance criteria, including the assays' fundamental aspects (sample and reagent stability, RNA extraction quality, RT-qPCR linearity, and analytical sensitivity and specificity), accuracy and precision, and reproducibility between laboratories. Results: Cxbladder had an analytical s

SUBMITTER: Harvey JC 

PROVIDER: S-EPMC11431456 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature