Arquer Diagnostics' ADXBLADDER becomes first bladder cancer urine test to undergo rigorous clinical trials in USA (PRNewswire)
"ADXBLADDER has become the first new generation urinary biomarker test for bladder cancer to undergo rigorous clinical trials in the USA in decades. The innovative and highly accurate test, developed by UK company Arquer Diagnostics, is already approved for use across Europe...ADXBLADDER is now being evaluated in a bladder cancer recurrence monitoring study in the US. With results of the study expected by the end of 2021, Arquer Diagnostics hopes to make a 510(k) premarket submission to the US Food and Drug Administration (FDA) to gain clearance from the organisation for ADXBLADDER to be commercialised in the US."