New Urine Test Outshines Traditional Methods in Bladder Cancer Detection

A recent study led by Dr. In Gab Jeong at the Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea, unveils a promising urine-based test for detecting bladder cancer. Published in JAMA Oncology, the study highlights the test's high sensitivity and specificity, making it a potential game-changer in the early diagnosis of high-grade or invasive bladder cancer. The study, financially supported by Genomictree Inc., involved 1,099 individuals with hematuria scheduled for cystoscopy within three months.

The participants, with a mean age of 65 years and predominantly male (55.9%), underwent urinary DNA methylation testing. Results revealed that 219 individuals had bladder cancer, including 176 cases of high-grade or invasive cancer. The innovative test demonstrated a sensitivity of 89.2% and a specificity of 87.8% for high-grade or invasive bladder cancer, surpassing the performance of traditional nuclear matrix protein 22 (NMP22) and urine cytology tests.

"In this multicenter study of individuals with hematuria, the urinary DNA methylation test showed 89% sensitivity for detecting high-grade or invasive bladder cancer, outperforming the NMP22 test or urine cytology test," said Dr. In Gab Jeong.

The DNA methylation test also showed a negative predictive value of 97.6%, indicating strong reliability in ruling out high-grade or invasive bladder cancer. For overall bladder cancer detection, the test achieved a sensitivity of 78.1% and specificity of 88.8%. However, its positive predictive value stood at only 61.3%, suggesting lower accuracy in confirming the presence of cancer with a positive result.

Despite its remarkable sensitivity, the test had lower specificity (87.8%) compared to the NMP22 (91.6%) and urine cytology tests (99.5%) for ruling out high-grade or invasive cancer. This aspect suggests that while the test is excellent at identifying patients without the disease, it may yield more false positives than its counterparts.

The study's findings are significant for the Republic of Korea and offer hope in improving bladder cancer diagnostics. However, experts caution that these results may not be universally applicable across different racial and ethnic groups.