Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement for medtech innovation briefings. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting

Published evidence

Two prospective studies involving 156 people under investigation for urothelial cancer are summarised in this briefing.

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

Overall, the quantity of evidence for URO17 is limited. There was 1 prospective study, and an abstract by the same author. The study populations of both studies may overlap.

The main study was at just 1 centre. Further studies at multiple sites are needed to validate the results when the test is used for initial diagnosis, and to provide evidence for when it is used to monitor for recurrence. Longer-term data, and data comparing it to other urinary biomarker tests would be helpful.

Vasdev et al. (2020)

Study size, design and location

A prospective blinded validation trial of 71 people due to have a biopsy because of suspected urothelial tract cancer. The author noted that people included had likely already had flexible cystoscopy before study recruitment.

Intervention and comparator

URO17 compared with biopsy histology.

Key outcomes

In people with no previously diagnosed bladder cancer (n=71), URO17 was shown to have a sensitivity of 100% and a specificity of 92.6%. Cystoscopy and biopsy were used as the reference standard. The positive predictive value was 0.957 and negative predictive value was 1. URO17 was positive in all people with urothelial malignancy regardless of grade or stage. No interobserver variability was identified between the 2 pathologists reporting the URO17 results. URO17 was positive in all of 28 people with malignancy confirmed by histology and in 35 of 36 people with malignancy detected by radiological imaging (97.2%).

Strengths and limitations

The study was in just 1 hospital.

Vasdev et al. (2020) [an abstract]

Intervention and comparator

URO17 compared with biopsy histology.

Key outcomes

URO17 had a sensitivity of 100% and a specificity of 60.5%. The results of a sub-analysis to determine confounding factors showed a sensitivity of 100% and specificity of 88.25%, with a negative predictive value of 1 and a positive predictive value of 0.93. URO17 was positive in all people with bladder cancer and no urothelial malignancy were found in any person with a negative URO17 result. The authors noted that there is a 5‑year study to examine its diagnostic utility in people who have had Bacillus Calmette-Guerin (BCG) therapy.

Strengths and limitations

This is a cross-sectional study. Strengths and limitations have not been assessed because limited information was reported in the abstract.


This is a single-use test.

Recent and ongoing studies

The Welsh Accelerate Programme at Cardiff University is evaluating URO17 for detecting bladder cancer and its economic effects on the NHS.

There is ongoing work led by Mr Vasdev on using URO17 as a home test for surveillance of the backlog of people with bladder cancer during the COVID‑19 pandemic.

The company notes there are studies in the US and European countries to assess the diagnostic accuracy of URO17.