To compare the sensitivity and specificity of the RNA tests with cytology and NMP22 assays (NMP22 BladderChek and NMP22 enzyme-linked immunosorbent assay [ELISA]) using cystoscopy as the reference, Paul O'Sullivan, Ph.D., of Pacific Edge Ltd. in Dunedin, New Zealand, and associates conducted a prospective study of 485 patients presenting with gross hematuria with no history of urothelial cancer.

Of 66 patients with urothelial carcinoma, the researchers found that uRNA detected 62.1 percent of the cases, compared with cytology (56.1 percent), NMP22 ELISA (50 percent), and BladderChek (37.9 percent). Cxbladder detected 82 percent of cases, including 100 percent of tumors stage 1 or greater and 97 percent of high-grade tumors. The specificity of Cxbladder and uRNA were prespecified at 85 percent, and the specificity of cytology, NMP22 ELISA, and BladderChek were 94.5, 88.0, and 96.4 percent, respectively. Cxbladder was able to differentiate between low-grade Ta tumors and other detected urothelial carcinoma with a sensitivity and a specificity of 91 and 90 percent, respectively.

"uRNA and Cxbladder showed improved sensitivity for the detection of urothelial carcinoma compared to the NMP22 assays," the authors write. "Stratification with Cxbladder provides a potential method to prioritize patients for the management of waiting lists."

Several authors disclosed financial ties (including employment) to Pacific Edge Ltd., which manufactures Cxbladder.

Abstract
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