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Development of a 90-Minute Integrated Noninvasive Urinary Assay for Bladder Cancer Detection

2017; Lippincott Williams & Wilkins; Volume: 199; Issue: 3 Linguagem: Inglês

10.1016/j.juro.2017.09.141

1527-3792

Ellen Wallace, Russell Higuchi, Malini Satya, Leena McCann, Mandy L.Y. Sin, Julia A. Bridge, Huilin Wei, Jun Zhang, Edith Y. Wong, Andrew M. Hiar, Kathleen E. Mach, Douglas S. Scherr, R. Blair Egerdie, Shoichiro Ohta, Wade J. Sexton, Maxwell V. Meng, Alon Z. Weizer, Michael Woods, G. Kenneth Jansz, Joseph Zadra, Yair Lotan, Bernard Goldfarb, Joseph C. Liao,

Urinary Tract Infections Management

No AccessJournal of UrologyAdult Urology1 Mar 2018Development of a 90-Minute Integrated Noninvasive Urinary Assay for Bladder Cancer Detection Ellen Wallace, Russell Higuchi, Malini Satya, Leena McCann, Mandy L.Y. Sin, Julia A. Bridge, Huilin Wei, Jun Zhang, Edith Wong, Andrew Hiar, Kathleen E. Mach, Douglas Scherr, R. Blair Egerdie, Shoichiro Ohta, Wade J. Sexton, Maxwell V. Meng, Alon Z. Weizer, Michael Woods, G. Kenneth Jansz, Joseph Zadra, Yair Lotan, Bernard Goldfarb, and Joseph C. Liao Ellen WallaceEllen Wallace Cepheid, Sunnyvale, California , Russell HiguchiRussell Higuchi Cepheid, Sunnyvale, California , Malini SatyaMalini Satya Cepheid, Sunnyvale, California , Leena McCannLeena McCann Cepheid, Sunnyvale, California , Mandy L.Y. SinMandy L.Y. Sin Department of Urology, Stanford University School of Medicine, Stanford, California Veterans Affairs Palo Alto Health Care System, Palo Alto, California , Julia A. BridgeJulia A. Bridge Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska , Huilin WeiHuilin Wei Cepheid, Sunnyvale, California , Jun ZhangJun Zhang Cepheid, Sunnyvale, California , Edith WongEdith Wong Cepheid, Sunnyvale, California , Andrew HiarAndrew Hiar Cepheid, Sunnyvale, California , Kathleen E. MachKathleen E. Mach Department of Urology, Stanford University School of Medicine, Stanford, California Veterans Affairs Palo Alto Health Care System, Palo Alto, California , Douglas ScherrDouglas Scherr Weill Cornell Medical College, New York, New York , R. Blair EgerdieR. Blair Egerdie Urology Associates/Urologic Medical Research, Kitchener, Ontario, Canada , Shoichiro OhtaShoichiro Ohta Kan-Etsu Hospital, Saitama, Japan , Wade J. SextonWade J. Sexton Moffitt Cancer Center, Tampa, Florida , Maxwell V. MengMaxwell V. Meng University of California-San Francisco, San Francisco, California , Alon Z. WeizerAlon Z. Weizer University of Michigan, Ann Arbor, Michigan , Michael WoodsMichael Woods University of North Carolina, Chapel Hill, North Carolina , G. Kenneth JanszG. Kenneth Jansz Burlington, Ontario, Canada , Joseph ZadraJoseph Zadra The Male/Female Health and Research Centre, Barrie, Ontario, Canada , Yair LotanYair Lotan University of Texas Southwestern Medical Center, Dallas, Texas , Bernard GoldfarbBernard Goldfarb North Bay, Ontario, Canada , and Joseph C. LiaoJoseph C. Liao Department of Urology, Stanford University School of Medicine, Stanford, California Veterans Affairs Palo Alto Health Care System, Palo Alto, California View All Author Informationhttps://doi.org/10.1016/j.juro.2017.09.141AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Despite suboptimal sensitivity urine cytology is often performed as an adjunct to cystoscopy for bladder cancer diagnosis. We aimed to develop a noninvasive, fast molecular diagnostic test for bladder cancer detection with better sensitivity than urine cytology while maintaining adequate specificity. Materials and Methods: Urine specimens were collected at 18 multinational sites from subjects prior to cystoscopy or tumor resection, and from healthy and other control subjects without evidence of bladder cancer. The levels of 10 urinary mRNAs were measured in a training cohort of 483 subjects and regression analysis was used to identify a 5-mRNA model to predict cancer status. The performance of the GeneXpert® Bladder Cancer Assay, an assay labeled for investigational use only to detect the 5 mRNAs ABL1, CRH, IGF2, ANXA10 and UPK1B, was evaluated in an independent test cohort of 450 participants. Results: In the independent test cohort the assay ROC curve AUC was 0.87 (95% CI 0.81–0.92). At an example cutoff point of 0.4 overall sensitivity was 73% while specificity was 90% and 77% in the hematuria and surveillance patient populations, respectively. Conclusions: We developed a 90-minute, urine based test that is simple to perform for the detection of bladder cancer. The test can help guide physician decision making in the management of bladder cancer. Additional evaluation in a prospective study is needed to establish the clinical usefulness of this assay. References 1 National Cancer Institute Surveillance, Epidemiology, and End Results Program. Available at https://seer.cancer.gov/statfacts/html/urinb.html. Accessed June 13, 2017. Google Scholar 2 : Recurrence, progression, and follow-up in non-muscle-invasive bladder cancer. Eur Urol2009; 8: 556. Google Scholar 3 : Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1 and CIS). Arnhem, The Netherlands: European Association of Urology2015. Google Scholar 4 : Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO Guideline. J Urol2016; 196: 1021. Link, Google Scholar 5 : Urine markers for bladder cancer surveillance: a systematic review. Eur Urol2005; 47: 736. Google Scholar 6 : Differences between local and review urinary cytology in diagnosis of bladder cancer. An interobserver multicenter analysis. Eur Urol2002; 41: 284. Google Scholar 7 : Current status of urinary biomarkers for detection and surveillance of bladder cancer. Urol Clin North Am2016; 43: 47. Google Scholar 8 : Technology for automated, rapid, and quantitative PCR or reverse transcription-PCR clinical testing. Clin Chem2005; 51: 882. Google Scholar 9 : Kinetic PCR analysis: real-time monitoring of DNA amplification reactions. Biotechnology (N Y)1993; 11: 1026. Google Scholar 10 : A multigene urine test for the detection and stratification of bladder cancer in subjects presenting with hematuria. J Urol2012; 188: 741. Link, Google Scholar 11 : Performance characteristics of a multigene urine biomarker test for monitoring for recurrent urothelial carcinoma in a multicenter study. J Urol2017; 197: 1419. Link, Google Scholar 12 : Gene expression test for the non-invasive diagnosis of bladder cancer: a prospective, blinded, international and multicenter validation study. Eur J Cancer2016; 54: 131. Google Scholar 13 : Expression of insulin-like growth factor (IGF)-II in human prostate, breast, bladder, and paraganglioma tumors. Cell Tissue Res1998; 291: 469. Google Scholar 14 : Urinary insulin-like growth factor 2 identifies the presence of urothelial carcinoma of the bladder. BJU Int2009; 103: 694. Google Scholar 15 : Human uroplakin lb gene structure and promoter analysis. Biochim Biophys Acta2002; 1576: 163. Google Scholar 16 : Detection of circulating cancer cells expressing uroplakins and epidermal growth factor receptor in bladder cancer subjects. Int J Cancer2004; 111: 934. Google Scholar 17 : Annexin A10 is an immunohistochemical marker for adenocarcinoma of the upper gastrointestinal tract and pancreatobiliary system. Histopathology2013; 63: 640. Google Scholar 18 : Expression of corticotropin-releasing hormone messenger ribonucleic acid in human pituitary corticotroph adenomas associated with proliferative potential. J Clin Endocrinol Metab2000; 85: 1220. Google Scholar 19 : Gene expression signature in urine for diagnosing and assessing aggressiveness of bladder urothelial carcinoma. Clin Cancer Res2010; 16: 2624. Google Scholar 20 : The emerging role of ABL kinases in solid tumors. Trends Cancer2015; 1: 110. Google Scholar © 2018 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byWoldu S, Ng C, Loo R, Slezak J, Jacobsen S, Tan W, Kelly J, Lough T, Darling D, van Kessel K, de Jong J, van Criekinge W, Shariat S, Hiar A, Brown S, Boorjian S, Barocas D, Svatek R and Lotan Y (2020) Evaluation of the New American Urological Association Guidelines Risk Classification for HematuriaJournal of Urology, VOL. 205, NO. 5, (1387-1393), Online publication date: 1-May-2021.Chang S (2020) Re: Urine Cytology is a Feasible Tool for Assessing Erythematous Bladder Lesions after bacille Calmette-Guérin (BCG) TreatmentJournal of Urology, VOL. 203, NO. 5, (879-879), Online publication date: 1-May-2020.Smith J (2017) This Month in Adult UrologyJournal of Urology, VOL. 199, NO. 3, (583-585), Online publication date: 1-Mar-2018. Volume 199Issue 3March 2018Page: 655-662Supplementary Materials Advertisement Copyright & Permissions© 2018 by American Urological Association Education and Research, Inc.Keywordspathologyhematuriaearly detection of cancermessengermolecularurinary bladder neoplasmsRNAAcknowledgmentsDrs. Andrew Rosenberg, Mid-Peninsula Urology, Burlingame, California; Thomas Davis, Wishard Memorial Hospital, Indianapolis, Indiana; Michael Cookson, Vanderbilt University Medical Center, Nashville, Tennessee; and Bernard Goldfarb, North Bay, Ontario, Canada, assisted with subject enrollment and the collection of pertinent clinical information.MetricsAuthor Information Ellen Wallace Cepheid, Sunnyvale, California Financial interest and/or other relationship with Cepheid. More articles by this author Russell Higuchi Cepheid, Sunnyvale, California Financial interest and/or other relationship with Cepheid. More articles by this author Malini Satya Cepheid, Sunnyvale, California Financial interest and/or other relationship with Cepheid. More articles by this author Leena McCann Cepheid, Sunnyvale, California Financial interest and/or other relationship with Cepheid. More articles by this author Mandy L.Y. Sin Department of Urology, Stanford University School of Medicine, Stanford, California Veterans Affairs Palo Alto Health Care System, Palo Alto, California More articles by this author Julia A. Bridge Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska Financial interest and/or other relationship with Cepheid. More articles by this author Huilin Wei Cepheid, Sunnyvale, California Financial interest and/or other relationship with Cepheid. More articles by this author Jun Zhang Cepheid, Sunnyvale, California Financial interest and/or other relationship with Cepheid. More articles by this author Edith Wong Cepheid, Sunnyvale, California Financial interest and/or other relationship with Cepheid. More articles by this author Andrew Hiar Cepheid, Sunnyvale, California More articles by this author Kathleen E. Mach Department of Urology, Stanford University School of Medicine, Stanford, California Veterans Affairs Palo Alto Health Care System, Palo Alto, California More articles by this author Douglas Scherr Weill Cornell Medical College, New York, New York More articles by this author R. Blair Egerdie Urology Associates/Urologic Medical Research, Kitchener, Ontario, Canada More articles by this author Shoichiro Ohta Kan-Etsu Hospital, Saitama, Japan More articles by this author Wade J. Sexton Moffitt Cancer Center, Tampa, Florida More articles by this author Maxwell V. Meng University of California-San Francisco, San Francisco, California More articles by this author Alon Z. Weizer University of Michigan, Ann Arbor, Michigan More articles by this author Michael Woods University of North Carolina, Chapel Hill, North Carolina More articles by this author G. Kenneth Jansz Burlington, Ontario, Canada Financial interest and/or other relationship with Cepheid. More articles by this author Joseph Zadra The Male/Female Health and Research Centre, Barrie, Ontario, Canada More articles by this author Yair Lotan University of Texas Southwestern Medical Center, Dallas, Texas Financial interest and/or other relationship with Cepheid. More articles by this author Bernard Goldfarb North Bay, Ontario, Canada More articles by this author Joseph C. Liao Department of Urology, Stanford University School of Medicine, Stanford, California Veterans Affairs Palo Alto Health Care System, Palo Alto, California More articles by this author Expand All Advertisement PDF downloadLoading ...