Performance of the URO17® Test in Detecting Bladder Cancer - Expert Commentary
Porten et al. aimed to further evaluate the performance of URO17®. The test was used on 152 participants undergoing procedures for urologic malignancies, of which 76 were cases and 76 were controls. The median age of cases was 70 and the median age of controls was 65. The majority of cases underwent endoscopic bladder procedures (90%) and 54% received intravesical therapy before the study. Over a third of patients exhibited urothelial carcinoma recurrence. Overall, the URO17® test was associated with a sensitivity of 90% and a specificity of 88% (n = 167). In patients with suspected urothelial carcinoma (n = 91), the sensitivity was 90% and specificity was 53%. Positive predictive value (PPV) was consistent across subgroups, but negative predictive value (NPV) varied based on the subgroup (67 – 100%). No controls had a positive URO17® result. The test outperformed urine cytology in detecting low-grade or high-grade disease. However, there were 21 false positive and 6 false negative results.
The URO17® test outperformed many existing non-invasive tests but had a low specificity rate. This is likely due to factors including inflammation or prior BCG therapy. The relatively high PPV and NPV values suggest URO17® could be useful for ruling out active urothelial cancer. Prospective validation studies in larger cohorts, particularly to distinguish between confounding factors such as previous treatment are warranted. As urine new cell-free DNA technologies mature, it will be important to compare cell-based and cell-free based methods for urothelial cancer detection.
Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine
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