Rigorous clinical trials of this MCM5 ELISA (enzyme-linked immunosorbent assay) test have been carried out in around 3,000 patients, showing it can rule out the presence of bladder cancer with a negative-predictive value (NPV) of 99% and it is already approved for use across EMEA.

The innovative test is also being evaluated in a bladder cancer recurrence monitoring study in the USA and, if the US Food and Drug Administration (FDA) gives it clearance to be commercialised, it would make ADXBLADDER the first, new generation urinary biomarker test for bladder cancer to be approved by the FDA in almost two decades.