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Development of a 90-Minute Integrated Noninvasive Urinary Assay for Bladder Cancer Detection
Ellen Wallace1, Russell Higuchi1, Malini Satya1
1Cepheid, Sunnyvale, California.
The Journal of Urology
|October 25, 2017
Summary
A new 90-minute urine test shows promise for detecting bladder cancer with 73% sensitivity and 90% specificity, offering a faster, noninvasive alternative to urine cytology.
Area of Science:
- Urology
- Molecular Diagnostics
- Oncology
Background:
- Urine cytology has suboptimal sensitivity for bladder cancer diagnosis.
- Current diagnostic methods often involve invasive procedures like cystoscopy.
- There is a need for noninvasive, sensitive, and specific bladder cancer detection methods.
Purpose of the Study:
- To develop a noninvasive, rapid molecular diagnostic test for bladder cancer.
- To achieve higher sensitivity than urine cytology while maintaining adequate specificity.
- To evaluate the performance of a novel 5-mRNA based assay.
Main Methods:
- Urine specimens collected from 18 multinational sites.
- A 5-mRNA model (ABL1, CRH, IGF2, ANXA10, UPK1B) developed using regression analysis on a training cohort (n=483).
- Performance evaluated using the GeneXpert® Bladder Cancer Assay in an independent test cohort (n=450).
Main Results:
- The assay demonstrated an ROC curve AUC of 0.87 in the test cohort.
- Overall sensitivity was 73% at a cutoff of 0.4.
- Specificity was 90% in hematuria patients and 77% in surveillance patients.
Conclusions:
- A 90-minute, urine-based test for bladder cancer detection was developed.
- The test is simple to perform and aids physician decision-making.
- Further prospective studies are required to establish clinical utility.
