URO17 for detecting bladder cancer

Level of innovation

Two experts thought URO17 is a newly emerging biomarker urine test for bladder cancer based on detecting the keratin 17 (K17) protein. One noted that URO17 had better diagnostic accuracy than other biomarker tests. For example, the sensitivity of ADXBLADDER ranges from 44% to 73% with a specificity between 66% and 71%; the sensitivity of EpiCheck is 64% with a specificity of 82%. Another expert said that the technology is a minor variation because it uses a different biomarker to other urine-based tests. The remaining expert did not think that the URO17 test was innovative, adding that there are many other urine-based tests to help diagnose bladder cancer.

Potential patient impact

The potential benefits identified by the experts included: improved identification of people with suspected bladder cancer based on its diagnostic utility, and avoiding unnecessary invasive cystoscopy. The experts thought that the test could be used to evaluate visible or non-visible haematuria, but cystoscopy remains standard care. Two experts were not convinced by the claimed benefits of the technology over traditional cytology, adding that initial cystoscopy would still be needed to assess other potential causes of haematuria, and that there is currently a lack of robust data to support the use of the URO17 test in routine clinical practice.

One expert considered that the URO17 test could be useful during the COVID‑19 pandemic in managing the waiting list for cystoscopy by identifying and prioritising high-risk patients.

Potential system impact

The main system benefit identified by the experts was better identification of people with bladder cancer, potentially leading to a release of resource because of reduced cystoscopy. One felt it was too early to say what the system benefits would be, but that there might be a significant impact if the diagnostic accuracy of URO17 was proven. All the experts believed adopting the technology would change the current care pathway if more robust data were to support its diagnostic accuracy.

URO17 is a laboratory-based assay, and most of the experts did not think any substantial changes to infrastructure or facilities were needed because biomarker assay testing is commonplace. All thought that the test would be relatively easy to use with a simple learning curve. No safety concerns or regulatory issues around the test were raised by the experts, although one noted that bladder cancer diagnosis would be delayed if the test performance was substandard.

General comments

The experts were aware of a number of biomarker urine tests for bladder cancer, but none is widely used in routine clinical practice. One explained that the main reason biomarker tests have not been adopted in practice is that the early data reporting high diagnostic accuracy often did not reflect how the test worked in clinical practice. Two experts thought it was too early to support the widespread use of URO17 in routine clinical practice in the NHS because of limited evidence. Most agreed that large-scale, multicentre studies are essential to improve the evidence base for the test.

One expert added that longer-term studies are needed on using URO17 for people who have had Bacillus Calmette-Guerin (BCG) or radiotherapy.