URO17 for detecting bladder cancer

The technology described in this briefing is URO17. It is a urine-based biomarker test to detect bladder cancer in people with symptoms of bladder cancer. It is also used to monitor for recurrence during treatment follow up.

The innovative aspect is that it is a non-invasive diagnostic tool that detects bladder cancer based on the novel biomarker keratin 17 (K17). It can help stratify patients with suspected bladder cancer and prioritise them for further secondary care investigations during the COVID‑19 pandemic.

The intended place in therapy would be used alongside cystoscopy as an alternative to other urine‑based tests.

The main points from the evidence summarised in this briefing are from 2 prospective studies including a total of 156 people with suspected bladder cancer. They show that URO17 had a sensitivity of 100% in detecting bladder cancer with a specificity of 60% to 93%.

The key uncertainty around the evidence is that it is from only 2 studies, 1 of which is an abstract. Further studies are needed to validate results when the test is used to help initial diagnosis, and to provide evidence for when it is used to monitor for recurrence. Longer-term data on larger populations and data from comparisons with other urinary biomarker tests would be helpful.

The cost of URO17 is £110 per test (excluding VAT).