SCIENTISTS have developed a non-invasive bisulphite sequencing test to detect bladder cancer using urine samples that matches the performance of a cystoscopy, the current clinical standard.
The UroMark test was developed by researchers at the University College of London (UCL), London, UK and uses genomic sequence to detect abnormal cancer DNA in a patient’s urine. The test could help to reduce costs in the management of bladder cancer as well as being a non-invasive alternative to cystoscopy procedures which currently cost more than £55 million a year in the UK.
In a proof-of-concept study, Prof John Kelly and Dr Andy Feber who led the research group at UCL defined a 150 CpG loci biomarker panel. Using the panel, they developed the UroMark test to detect bladder cancer in urinary sediment. The researchers validated the test in a cohort of 274 non-cancer (n=167) and cancer (n=107) urine samples with an area under the curve of 97%. The classifier sensitivity was 98%, specificity of 97%, and negative predictive value of 97% for the detection of bladder cancer compared to non-cancer urine. The researchers note the sensitivity of a cystoscopy of 90–97%.
The researchers have also received £1.42 million of funding from the Medical Research Council (MRC) for two larger trials that are currently underway across 32 hospitals in the UK. The trials will aim to confirm the accuracy of the UroMark before it becomes available for clinical use.
UroMark could be used by general practitioners (GPs) for earlier tests to detect bladder cancer, rather than requiring patients to visit a hospital or clinic for more expensive procedures. “We have good evidence that patients, particularly females, are diagnosed late with bladder cancer and often patients visit a GP several times with symptoms prior to detection. Having the UroMark test available to GPs will mean that patients can be tested at an early state to rule out bladder cancer,” explained Prof Kelly.
Jack Redden, Reporter