Genomic Urine Test Predicts Bladder Cancer Recurrence Before Clinical Symptoms Emerge

Bladder cancer, a highly prevalent disease, ranks among the UK's top ten most common cancers and the fifth most common across the European Union. Unfortunately, advanced bladder cancer has a bleak prognosis, as only approximately 50% of patients survive beyond five years after diagnosis. This is largely attributed to late diagnosis and recurring bouts of the disease. Nevertheless, the odds of survival escalate significantly when bladder cancer is identified in its early stages – over 80% of patients diagnosed early survive for at least five years. Now, new research has shown that a non-invasive genomic urine test can detect bladder cancer or predict its recurrence before clinical signs or symptoms appear.

UroAmp from Convergent Genomics (South San Francisco, CA, USA) employs next-generation DNA sequencing to deeply examine 60 key genes related to urothelial cancer, hunting for mutations, while simultaneously broadly assessing genome-wide changes. The outcome is a comprehensive genomic profile offering insights into a patient's cancer prognosis and predicted responses to genome-targeted drug treatments. In a multi-center case-control study, UroAmp's diagnostic and prognostic performance for bladder cancer was measured against standard-of-care methods such as cystoscopy, cytology, and pathology. The study encompassed 581 patients, including those under evaluation for hematuria (blood in urine) and those undergoing post-surgery recurrence monitoring.

Notably, UroAmp demonstrated its capability to detect minimal residual disease in surveillance patients post-cystoscopy and urine cytology, with several predicted recurrences identified over a year before clinical diagnosis. The study revealed that high-risk patients were six times more likely to experience cancer recurrence compared to low-risk patients – a crucial insight given the disease's overall recurrence rate of 60% to 70% following treatment. Additionally, UroAmp showcased a sensitivity of 95% and specificity of 90% in detecting bladder tumors during the initial diagnosis phase. This study builds upon recent breakthroughs from large public research initiatives, further defining the key genome segments that are most commonly mutated in bladder cancer. The research also identified gene associations with tumor grade and bladder invasion. A UroAmp molecular grade prediction algorithm accurately identified high-grade cancers with a positive predictive value of 88% and specificity of 95%. Several mutations discovered in this research are also under study as potential targets for new drugs or for predicting responses to existing FDA-approved therapies.

"These findings demonstrate the power of genomics in detecting minimal residual disease from urine and accurately stratifying a bladder cancer patient's risk to better inform decisions about their treatment and surveillance," said Keyan Salari, MD, PhD, lead study author and Assistant Professor of Urology at Harvard Medical School and Massachusetts General Hospital

"The combination of prognostic insights, therapeutic targets, and the ability to non-invasively monitor genomic response over time with UroAmp presents a new paradigm to enhance clinical trials and to ultimately better personalize care and improve outcomes," added study co-author Trevor Levin, Ph.D., Founder and CEO, Convergent Genomics.

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