{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T21:42:17Z","timestamp":1793828537143,"version":"4.6.1"},"reference-count":80,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2023,12,22]],"date-time":"2023-12-22T00:00:00Z","timestamp":1703203200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Cancer Research Grant from Pyung-Ya Foundation"},{"name":"Biomarker Research Program Grant from HJM Cancer Research Foundation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJMS"],"abstract":"<jats:p>Bladder cancer (here we refer to transitional carcinoma of bladder) is a major cause of morbidity and mortality in the Western world, and recent understanding of its etiology, the molecular characteristics associated with its progression, renders bladder cancer an ideal candidate for screening. Cystoscopy is invasive and sometimes carries unwanted complications, but it is the gold standard for the detection of bladder cancer. Urine cytology, while the most commonly used test as an initial screening tool, is of limited value due to its low sensitivity, particularly for low-grade tumors. Several new \u201cmolecular assays\u201d for the diagnosis of urothelial cancer have been developed over the last two decades. Here, we have established our new bladder cancer test based on an assay established for the Early Detection Research Network (EDRN) study. As a part of the study, a quality control CLIA\/College of American Pathology (CAP) accredited laboratory, (QA Lab), University of Maryland Baltimore Biomarker Reference Laboratory (UMB-BRL), performed quality assurance analysis. Quality assurance measures included a concordance study between the testing laboratory (AIBioTech), also CLIA\/CAP accredited, and the QA lab to ensure that the assay was performed and the results were analyzed in a consistent manner. Therefore, following the technical transfer and training of the microsatellite analysis assay to the UMB-BRL and prior to the initiation of analysis of the clinical samples by the testing lab, a series of qualification studies were performed. This report details the steps taken to ensure qualification of the assay and illustrates the technical challenges facing biomarker validation of this kind.<\/jats:p>","DOI":"10.3390\/ijms25010209","type":"journal-article","created":{"date-parts":[[2023,12,24]],"date-time":"2023-12-24T20:44:15Z","timestamp":1703450655000},"page":"209","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Qualification of the Microsatellite Instability Analysis (MSA) for Bladder Cancer Detection: The Technical Challenges of Concordance Analysis"],"prefix":"10.3390","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0009-0000-1966-8877","authenticated-orcid":false,"given":"Thomas","family":"Reynolds","sequence":"first","affiliation":[{"name":"NEXT Bio-Research Services, LLC, 11601 Ironbridge Road, Suite 101, Chester, VI 23831, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Bertsche","sequence":"additional","affiliation":[{"name":"NEXT Bio-Research Services, LLC, 11601 Ironbridge Road, Suite 101, Chester, VI 23831, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Moon","sequence":"additional","affiliation":[{"name":"HJM Cancer Research Foundation Corporation, 10606 Candlewick Road, Lutherville, MD 21093, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3863-4298","authenticated-orcid":false,"given":"Chulso","family":"Moon","sequence":"additional","affiliation":[{"name":"HJM Cancer Research Foundation Corporation, 10606 Candlewick Road, Lutherville, MD 21093, USA"},{"name":"BCD Innovations USA, 10606 Candlewick Road, Lutherville, MD 21093, USA"},{"name":"Department of Otolaryngology-Head and Neck Surgery, The Johns Hopkins Medical Institution, Cancer Research Building II, 5M3, 1550 Orleans Street, Baltimore, MD 21205, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,12,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"812","DOI":"10.1126\/science.8484121","article-title":"Clues to the pathogenesis of familial colorectal cancer","volume":"260","author":"Aaltonen","year":"1993","journal-title":"Science"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"558","DOI":"10.1038\/363558a0","article-title":"Ubiquitous somatic mutations in simple repeated sequences reveal a new mechanism for colonic carcinogenesis","volume":"363","author":"Ionov","year":"1993","journal-title":"Nature"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"816","DOI":"10.1126\/science.8484122","article-title":"Microsatellite instability in cancer of the proximal colon","volume":"260","author":"Thibodeau","year":"1993","journal-title":"Science"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"673","DOI":"10.1093\/carcin\/bgm228","article-title":"Carcinogenesis and microsatellite instability: The interrelationship between genetics and epigenetics","volume":"29","author":"Imai","year":"2008","journal-title":"Carcinogenesis"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"2745","DOI":"10.3748\/wjg.v18.i22.2745","article-title":"Interrelationship between microsatellite instability and microRNA in gastrointestinal cancer","volume":"18","author":"Yamamoto","year":"2012","journal-title":"World J. 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