EarlyTect BCD, a Streamlined PENK Methylation Test in Urine DNA, Effectively Detects Bladder Cancer in Patients with Hematuria

被引:3
作者
Bang, Bo-Ram [1 ]
Zhong, Jin [2 ]
Oh, Tae Jeong [4 ]
Lee, Ji Yong [5 ]
Seo, Yangyei [4 ]
Woo, Min A. [4 ]
Lim, Jae Sung [5 ]
Na, Yong Gil [5 ]
Song, Ki Hak [5 ]
Shin, Ju Hyun [5 ]
Lee, Justin Junguek [1 ]
Im, Chan Su [1 ]
Kim, Seoyong [1 ]
Beqaj, Safedin [1 ]
Shirk, Joseph D. [3 ,6 ]
Ke, Katelyn W. [2 ]
Vallone, John [2 ]
An, Sungwhan [1 ,4 ]
机构
[1] Promis Diagnost Inc, Irvine, CA USA
[2] VA Greater Los Angeles Med Ctr, Pathol & Lab Med Serv, Los Angeles, CA USA
[3] VA Greater Los Angeles Med Ctr, Dept Urol, Los Angeles, CA USA
[4] Genomictree Inc, 44-6 10 Ro Techno, Daejeon 34027, South Korea
[5] Chungnam Natl Univ, Coll Med, Dept Urol, Daejeon, South Korea
[6] UCLA, David Geffen Sch Med, Dept Urol, Los Angeles, CA USA
关键词
TRANSITIONAL-CELL CARCINOMA; IDENTIFICATION;
D O I
10.1016/j.jmoldx.2024.04.001
中图分类号
R36 [病理学];
学科分类号
100104 ;
摘要
The current noninvasive diagnostic approaches for detecting bladder cancer (BC) often exhibit limited clinical performance, especially for the initial diagnosis. This study aims to evaluate the validity of a streamlined urine-based PENK methylation test called EarlyTect BCD in detecting BC in patients with hematuria scheduled for cystoscopy in Korean and American populations. The test seamlessly integrates two steps, linear target enrichment and quantitative methylation-specific PCR within a single closed tube. The detection limitation of the test was approximately two genome copies of methylated PENK per milliliter of urine. In the retrospective training set (n = 105), an optimal cutoff value was determined to distinguish BC from non-BC, resulting in a sensitivity of 87.3% and a specificity of 95.2%. In the prospective validation set (n = 210, 122 Korean and 88 American patients), the overall sensitivity for detecting all stages of BC was 81.0%, with a specificity of 91.5% and an area under the curve value of 0.889. There was no significant difference between the two groups. The test achieved a sensitivity of 100% in detecting high-grade Ta and higher stages of BC. The negative predictive value of the test was 97.7%, and the positive predictive value was 51.5%. The findings of this study demonstrate that EarlyTect BCD is a highly effective noninvasive diagnostic tool for identifying BC among patients with hematuria. (J Mol Diagn 2024, 26: 613-623; https://doi.org/10.1016/j.jmoldx.2024.04.001)
引用
收藏
页码:613 / 623
页数:11
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