Development of a 90-Minute Integrated Noninvasive Urinary Assay for Bladder Cancer Detection
| Autor: | Maxwell V. Meng, G. Kenneth Jansz, Joseph C. Liao, Joseph Zadra, Wade J. Sexton, Russell Higuchi, Leena McCann, R. Blair Egerdie, Malini Satya, Jun Zhang, Shoichiro Ohta, Kathleen E. Mach, Julia A. Bridge, Michael Woods, Andrew M. Hiar, Ellen Wallace, Mandy L. Y. Sin, Huilin Wei, Douglas S. Scherr, Bernard Goldfarb, Yair Lotan, Edith Wong, Alon Z. Weizer |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Genetic Markers Male medicine.medical_specialty Pathology Time Factors Adolescent Urology Urinary system 030232 urology & nephrology Urine Real-Time Polymerase Chain Reaction 03 medical and health sciences Young Adult 0302 clinical medicine medicine Biomarkers Tumor Humans Prospective Studies RNA Neoplasm Urine cytology Aged Aged 80 and over Carcinoma Transitional Cell Bladder cancer medicine.diagnostic_test business.industry Carcinoma in situ Cancer Cystoscopy Middle Aged medicine.disease ROC Curve Urinary Bladder Neoplasms 030220 oncology & carcinogenesis Cohort Female business Follow-Up Studies |
| Zdroj: | The Journal of urology. 199(3) |
| ISSN: | 1527-3792 |
| Popis: | 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.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.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.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. |
| Databáze: | OpenAIRE |
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