Clinical background

In the EU and US there are some 136,000 new cases of bladder cancer each year. Patients commonly present with blood in the urine (haematuria) or other lower urinary tract symptoms, although only a small minority of these patients will have cancer.

Early treatment improves outcomes but a high rate of recurrence means that post-treatment surveillance of patients is essential. About half a million people in the EU and US require regular post-treatment surveillance testing.

Currently, differential diagnosis of haematuria patients and surveillance testing for bladder cancer both rely on cystoscopy (bladder endoscopy), an expensive procedure that can miss some tumours, and which can cause tissue damage or infection. Cystoscopy is sometimes supported by a voided urine cytology test, involving microscopic examination of cells, but this procedure lacks sensitivity.

The performance characteristics of UroSens’ new test may allow it to be used in both initial diagnosis and in follow up surveillance testing, thereby saving healthcare systems the expense of large numbers of cystoscopies and patients the discomfort of invasive procedures.

The test currently in development is based on detecting the protein Mcm5 in patients’ urine, the clinical efficacy of which has already been demonstrated. The test was shown not to be affected by blood in the sample or by inflammatory processes.