Further analyses in the Journal of Urology study showed Cxbladder Monitor had 95% sensitivity for detecting recurrent disease with a high risk of progression (defined as all high-grade disease or low grade, stage ≥T1), as well as high sensitivity of 86% for detecting low-grade Ta disease, which also outperformed the other comparator tests. In addition, Cxbladder Monitor’s diagnostic performance was similar regardless of patient age, gender, and tumor stage. History of intravesical bacillus Calmette-Guérin treatment within the previous 6 months did not alter the test’s sensitivity. The rate of false-negative results was <1.5%.
The Urologic Oncology study comparing Cxbladder Monitor with other noninvasive urine tests for ruling out recurrent UC analyzed >1,000 urine samples provided by more than 800 patients undergoing surveillance for recurrent UC. Patients were recruited over a 3-year period from urology practices across the U.S. In this study, Cxbladder Monitor demonstrated 91% sensitivity and 96% NPV. Sensitivity of the other tests studied (cytology, NMP22 enzyme-linked immunosorbent assay, NMP22 BladderChek, UroVysion FISH) ranged from 11% to 36%, and the NPV for the other tests ranged from 86% to 92%. There were 14 false negative results with Cxbladder Monitor, and all of those samples also tested negative with each of the other tests.
Dr. Lotan said it is still not clear how to treat patients with a positive biomarker test in the setting of a normal cystoscopy. In that situation and considering available evidence, an intraoperative biopsy is likely not indicated based on a positive result from any commercially available biomarker test. Speaking specifically about Cxbladder Monitor, he said, “The role of this test in clinical practice still needs to be clarified. Used in conjunction with cystoscopy, a negative result can be reassuring. It may also be of value in patients at low or intermediate risk for recurrence who want to avoid cystoscopy, but the safety of avoiding cystoscopy in this setting will need to be verified.”
Cxbladder was recently included in the Federal Supply Schedule and covered by TriCare, and is currently being adopted by VA Centers across the U.S.
Dr. Lotan has consulted with Pacific Edge, primarily on study design and cost issues. Several of the authors of both studies have a financial and/or other relationship with Pacific Edge.
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