Ellen Wallace1, Russell Higuchi2, Malini Satya2, Leena McCann2, Mandy L Y Sin3, Julia A Bridge4, Huilin Wei2, Jun Zhang2, Edith Wong2, Andrew Hiar2, Kathleen E Mach3, Douglas Scherr5, R Blair Egerdie6, Shoichiro Ohta7, Wade J Sexton8, Maxwell V Meng9, Alon Z Weizer10, Michael Woods11, G Kenneth Jansz12, Joseph Zadra13, Yair Lotan14, Bernard Goldfarb15, Joseph C Liao3. 1. Cepheid, Sunnyvale, California. Electronic address: ellen.wallace@cepheid.com. 2. Cepheid, Sunnyvale, California. 3. Department of Urology, Stanford University School of Medicine, Stanford, California; Veterans Affairs Palo Alto Health Care System, Palo Alto, California. 4. Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska. 5. Weill Cornell Medical College, New York, New York. 6. Urology Associates/Urologic Medical Research, Kitchener, Ontario, Canada. 7. Kan-Etsu Hospital, Saitama, Japan. 8. Moffitt Cancer Center, Tampa, Florida. 9. University of California-San Francisco, San Francisco, California. 10. University of Michigan, Ann Arbor, Michigan. 11. University of North Carolina, Chapel Hill, North Carolina. 12. Burlington, Ontario, Canada. 13. The Male/Female Health and Research Centre, Barrie, Ontario, Canada. 14. University of Texas Southwestern Medical Center, Dallas, Texas. 15. North Bay, Ontario, Canada.
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.
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.
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