PENK methylation test has high sensitivity and specificity for detecting bladder cancer in patients with hematuria
By Elana Gotkine HealthDay Reporter
MONDAY, Aug. 21, 2023 (HealthDay News) — A urine-based DNA methylation test can accurately detect bladder cancer in patients with hematuria, according to a study published online June 14 in The Journal of Molecular Diagnostics.
Tae Jeong Oh, from Genomictree, Inc. in Daejeon, South Korea, and colleagues introduced and validated a urine-based DNA methylation test for bladder cancer in patients with hematuria. The test detects PENK methylation in urine DNA using linear target enrichment and quantitative methylation-specific PCR. The case-control study groups included 175 patients with bladder cancer and 143 patients without bladder cancer with hematuria, and the clinical study included 366 patients.
The researchers found that the test’s optimal cutoff value was determined by distinguishing between the two case-control groups, achieving overall sensitivity and specificity of 86.9 and 91.6 percent, respectively, with an area under the curve of 0.892. Test performance was assessed in a validation clinical study involving 366 patients with hematuria scheduled for cystoscopy, which demonstrated sensitivity and specificity of 84.2 and 95.7 percent, respectively, and an area under the curve of 0.900 for detecting 38 cases of bladder cancer. The sensitivity reached 92.3 percent for detecting Ta high grade and higher stages of bladder cancer. The negative predictive value of the test was 98.2 percent and positive predictive value was 68.7 percent.
“The present study showcases a breakthrough in diagnosing bladder cancer through a simple and effective diagnostic test that eliminates the need for unnecessary cystoscopy procedures,” coauthor Sungwhan An, Ph.D., also from Genomictree, said in a statement. “The test has the potential to significantly reduce bladder cancer-related deaths and medical expenses.”
Several authors are employees and shareholders of Genomictree and Promis Diagnostics.
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