Urine-based Test Shows Promise in Detecting Bladder Cancer

TOPLINE:

A urinary DNA methylation test demonstrated high sensitivity and specificity for detecting high-grade or invasive bladder cancer, outperforming both nuclear matrix protein 22 (NMP22) and urine cytology tests in sensitivity. However, the new test’s positive predictive value is suboptimal, indicating limitations in confirming the presence of high-grade or invasive bladder cancer.

METHODOLOGY:

• Cystoscopy, the standard for diagnosing bladder cancer, is invasive and high cost. Emerging biomarker tests, such as the investigational urinary DNA methylation test, can offer less invasive, cost-effective options for early bladder cancer detection.
• Researchers evaluated the performance of the urinary DNA methylation test in 1099 individuals (mean age, 65 years; 55.9% men) with hematuria who were scheduled for cystoscopy within 3 months.
• Urine samples were collected for DNA methylation, NMP22, and urine cytology tests, and patients underwent cystoscopy.
• Primary outcomes included sensitivity and specificity for high-grade or invasive bladder cancer. Secondary outcomes involved accuracy for overall bladder cancer detection and comparisons with NMP22 and urine cytology tests.

TAKEAWAY:

• Overall, 219 participants had bladder cancer, including 176 with high-grade or invasive cancer. The urinary DNA methylation test showed 89.2% sensitivity and 87.8% specificity for high-grade or invasive bladder cancer as well as a sensitivity of 78.1% and specificity of 88.8% for overall bladder cancer.
• The test achieved a negative predictive value of 97.6%, indicating strong reliability in ruling out high-grade or invasive bladder cancer. However, the test’s positive predictive value was only 61.3%, indicating a lower likelihood that a patient with a positive test result actually has the condition.
• The DNA methylation test had superior sensitivity for high-grade or invasive bladder cancer (89.2% vs 51.5% and 39.7%, respectively) and overall bladder cancer (78.1% vs 44.1% and 32.3%, respectively) than the NMP22 and urine cytology tests.
• However, the DNA methylation test had lower specificity than the NMP22 test (91.6%) and the urine cytology test (99.5%) for ruling out high-grade or invasive cancer.

IN PRACTICE:

“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,” the authors concluded. However, “while this test had an excellent negative predictive value, its positive predictive value was suboptimal,” the authors added.

SOURCE:

This study, led by In Gab Jeong, MD, PhD, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea, was published online in JAMA Oncology.

LIMITATIONS:

A significant proportion of enrolled participants who provided informed consent were not evaluated according to the study protocol. As the study population represented the Republic of Korea, the results might not be generalizable to other racial and ethnic groups.

DISCLOSURES:

Genomictree Inc., Daejeon, Republic of Korea, provided financial support for this study and supplied all urinary DNA methylation tests. The authors reported no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.