Florence Le Calvez-Kelm

Urinary UroAmp Test Detected Bladder Cancer Years Before Clinical Diagnosis

MedicalResearch.com Interview with:

Florence Le Calvez-Kelm

Dr. Le Calvez-Kelm

Florence Le Calvez-Kelm, Ph.D.
Genomic Epidemiology Branch
International Agency for Research on Cancer
Lyon, France and

Trevor Levin Ph.D. CEO of Convergent Genomics that produces the Uroamp assay San Francisco, CA

Dr. Levin

Trevor Levin Ph.D.

Founder and CEO of Convergent Genomics that produces the Uroamp assay
San Francisco, CA



MedicalResearch.com: What is the background for this study?

Response: Bladder cancer is one of the most expensive and challenging to diagnose and treat. Therefore, identifying cost-effective urine bladder cancer biomarkers to complement or replace the gold-standard invasive and costly cystoscopy for the early detection and monitoring of this highly recurrent disease is crucial. At the international Agency for research on Cancer (IARC-WHO), we have developed a simple urine-based assay TERT promoter mutations, the most common mutations in bladder cancer, and showed that the urine biomarker could detect bladder cancer patients at diagnosis but many years prior to clinical diagnosis. However, in this study, we wanted to see whether a more comprehensive genomic profiling of urine samples collected years prior to clinical diagnosis of bladder cancer could identify even more patients before they develop any symptoms.

The study was based on the UroAmp test, a general urine test that identifies mutations in 60 genes, developed by the Oregon Health Science University spin out company, Convergent Genomics. Drawing on previous research to identify genetic mutations linked to bladder cancer, the research team narrowed the new test down to focus on mutations within just ten genes.

Working with colleagues from the Tehran University of Medical Sciences in Iran, they trialled the potential new test using samples from the Golestan Cohort Study, which has tracked the health of more than 50,000 participants over ten years, all of whom provided urine samples at recruitment. Forty people within the study developed bladder cancer during that decade, and the team were able to test urine samples from twenty-nine of them, along with samples from 98 other similar participants as controls.

MedicalResearch.com: What are the main findings?

Response:  Of the 29 participants who’d developed bladder cancer within the Golestan cohort, the test was able to accurately predict future bladder cancer in 19 (66%) of them, even though urine samples had been taken up to 12 years before clinical diagnosis. Fourteen of these participants were diagnosed with bladder cancer within seven years of urine collection, and the test was able to predict cancer in 12 (86%) of these.  The test was accurately negative in 94 of the 98 participants (96%) who would not develop cancer in the future. Among those where the test was negative but who did eventually develop bladder cancer, no cancer was diagnosed until at least six years after the urine collection.

MedicalResearch.com: Is this profiling commercially available?  Can it also screen for kidney cancer?  

Response:  UroAmp is currently available in a small number of select urology centers across the US, as part of an early pilot testing program. UroAmp is not yet reimbursed by Medicare but broader availability through cash payment and in-network negotiations with insurance companies are slated to begin by the end of the second quarter of 2023.

MedicalResearch.com: Can it also screen for kidney cancer?  

Response: UroAmp is currently validated for supporting the initial diagnosis and recurrence surveillance of bladder cancer/urothelial carcinoma. UroAmp is not currently indicated for screening of kidney cancer, although this is an active area of research and further investigation.

MedicalResearch.com: What recommendations do you have for future research as a results of this study?

Response: We have identified the most significant acquired genetic mutations that can be detected in urine, which could increase the risk of developing bladder cancer within ten years. These findings are promising for the non-invasive early detection of bladder cancer. These preliminary steps are important in demonstrating the potential utility of a urine test as an alternative to invasive examinations. However, it is crucial that these findings are replicated in larger cohorts to ensure their validity. Additionally, cost-effectiveness analyses should be conducted to evaluate whether the use of the urine test could be a more economical option for health services in managing bladder cancer.

MedicalResearch.com: Is there anything else you would like to add?

Clinical implications of the research : Currently, patients presenting with blood in their urine, the primary symptom of bladder cancer, are typically referred to urologists for further examinations such as cystoscopies and scans. However, as only a small percentage (3-20%) of these patients will actually be diagnosed with bladder cancer, a urine test for genetic mutations could be useful in triaging patients who require further diagnostic procedures and those who do not. This could significantly improve the quality of life for patients.


Urinary comprehensive genomic profiling predicts urothelial cancer up to 12 years ahead of clinical diagnosis: An expanded analysis of the Golestan Cohort Study

DOI: 10.1016/S0302-2838(23)00317-2
Presented at EUA 2023 2023 EUA Annual Conference

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Last Updated on March 27, 2023 by Marie Benz