Convergent Genomics has announced that its new genomic urine test was able to precisely identify bladder cancer up to 12 years before clinical signs and symptoms appear in a new study.
The UroAmp test leverages next-generation DNA sequencing and machine-learning techniques to examine urine for mutations in 60 specific genes associated with bladder cancer.
In addition, it assesses the complete genome for comprehensive analysis.
As part of the study, a group of researchers from the US, France and Iran focused on a subset of ten genes with a predictive value for future bladder cancer risk.
Convergent Genomics received funding for the study from the National Cancer Institute through a Small Business Innovation Research grant.
The University of Texas Southwestern Medical Center urologic oncology chief and study co-author Dr Yair Lotan said: “This is the first study to show comprehensive genomic profiling of somatic mutations can detect preclinical urothelial cancer more than a decade ahead of a natural diagnosis.”
The UroAmp was investigated by researchers using two different approaches.
Initially, a case-control study was performed, involving the analysis of urine samples obtained from 96 control subjects and 70 individuals diagnosed with bladder cancer.
The UroAmp test demonstrated an 86% sensitivity in predicting new tumours, while its overall sensitivity was 71% for new and recurrent tumours. It found the specificity at 94%.
Another study implemented a nested case-control approach as part of the prospective Golestan Cohort Study, which encompasses urine samples collected from more than 50,000 individuals up to 12 years ago.
Researchers conducted an analysis of the urine samples of 29 individuals who had been diagnosed with bladder cancer and compared it to 98 control subjects who had never experienced this disease.
The UroAmp test accurately forecasted future cancer in 66% of cases, demonstrating a specificity of 94%.