Slightly higher negative predictive value seen
Analyses comparing the diagnostic performance of Cxbladder with cytology showed that the urinary biomarker test had a slightly higher negative predictive value, 97.4% versus 92.6%. More noteworthy, however, was the finding that Cxbladder had a much lower false-negative rate than cytology, missing only 8.5% of pathology-confirmed tumors compared with 63% that were missed by cytology.
In the subgroup of 153 samples with atypical cytology, 26 (17%) were confirmed by pathology as positive for UC. Cxbladder correctly identified all 26 tumors, including the two found in the 14 patients who had atypical cytology and equivocal cystoscopy.
“The latter two cases were high-risk tumors and included a high-grade ≥T1 UC and one carcinoma in situ,” said Dr. Konety. “Further study is warranted to investigate the value of Cxbladder in cases where cytology is atypical and cystoscopy is indeterminate.”
Dr. Konety conducts research for Pacific Edge, several of his co-authors are researchers/consultants for Pacific Edge, and one co-author is an employee of the company.