{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T07:34:23Z","timestamp":1774856063201,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T00:00:00Z","timestamp":1772755200000},"content-version":"vor","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJUI Compass"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      This study aims to develop and clinically evaluate EarlyTect BCD Plus, a urine\u2010based assay measuring two methylation sites of the\n                      <jats:italic>PENK<\/jats:italic>\n                      gene, and to assess its diagnostic performance and clinical utility according to haematuria risk stratification.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      A dual\u2010target quantitative methylation\u2010specific PCR assay was optimized using the\n                      <jats:italic>PENK<\/jats:italic>\n                      gene and evaluated in 892 patients with haematuria from Korea and the United States who underwent cystoscopy and histopathology. Urine DNA was analysed for two\n                      <jats:italic>PENK<\/jats:italic>\n                      methylation markers, and test results were interpreted using a combined algorithm. Diagnostic accuracy was assessed, and clinical utility was further analysed for patients stratified by the 2025 AUA\/SUFU haematuria guideline risk categories.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In the pooled cohort (gross haematuria,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009509; microhaematuria,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009366; unspecified haematuria,\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200917), EarlyTect BCD Plus achieved a sensitivity of 87.7% (95% CI, 81.5%\u201392.5%), specificity of 82.5% (95% CI, 79.6%\u201385.2%) and negative predictive value (NPV) of 97.0% (95% CI, 95.5%\u201398.0%). Sensitivity for Ta\u2010LG tumours improved to 60.5% compared with the original single\u2010marker assay, while high\u2010grade tumours were detected with 96.6% sensitivity. In the intermediate\u2010risk group, NPVs were 99.1% for all BC and 100% for high\u2010grade BC.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>EarlyTect BCD Plus significantly enhances detection of Ta\u2010LG bladder cancer while maintaining high specificity. Its high NPV supports use as a non\u2010invasive adjunct and triage tool, allowing deferral of cystoscopy in selected haematuria patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bco2.70178","type":"journal-article","created":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T03:02:09Z","timestamp":1773025329000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["EarlyTect BCD Plus: A urine\u2010based dual site PENK methylation test for risk\u2010based cystoscopy triage in haematuria"],"prefix":"10.1002","volume":"7","author":[{"given":"Tae Jeong","family":"Oh","sequence":"first","affiliation":[{"name":"Genomictree, Inc.  Daejeon Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bo\u2010Ram","family":"Bang","sequence":"additional","affiliation":[{"name":"Promis Diagnostics, Inc.  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jae Hee","family":"Hwang","sequence":"additional","affiliation":[{"name":"Genomictree, Inc.  Daejeon Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yangyei","family":"Seo","sequence":"additional","affiliation":[{"name":"Genomictree, Inc.  Daejeon Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seoyong","family":"Kim","sequence":"additional","affiliation":[{"name":"Promis Diagnostics, Inc.  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sujin","family":"Gu","sequence":"additional","affiliation":[{"name":"Promis Diagnostics, Inc.  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Safedin","family":"Beqaj","sequence":"additional","affiliation":[{"name":"Promis Diagnostics, Inc.  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2085-2844","authenticated-orcid":false,"given":"Theo","family":"deVos","sequence":"additional","affiliation":[{"name":"Promis Diagnostics, Inc.  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Justin Junguek","family":"Lee","sequence":"additional","affiliation":[{"name":"Promis Diagnostics, Inc.  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jin","family":"Zhong","sequence":"additional","affiliation":[{"name":"Department of Medicine University of California, Riverside  Riverside California USA"},{"name":"Pathology &amp; Laboratory Medicine Service VA Greater Los Angeles Medical Center  Los Angeles California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph D.","family":"Shirk","sequence":"additional","affiliation":[{"name":"Department of Urology VA Greater Los Angeles Medical Center  Los Angeles California USA"},{"name":"Department of Urology David Geffen School of Medicine at UCLA  Los Angeles California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katelyn W.","family":"Ke","sequence":"additional","affiliation":[{"name":"Pathology &amp; Laboratory Medicine Service VA Greater Los Angeles Medical Center  Los Angeles California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Vallone","sequence":"additional","affiliation":[{"name":"Pathology &amp; Laboratory Medicine Service VA Greater Los Angeles Medical Center  Los Angeles California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sungwhan","family":"An","sequence":"additional","affiliation":[{"name":"Genomictree, Inc.  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