ADXBLADDER for detecting bladder cancer

Level of innovation

One commentator did not think that ADXBLADDER was innovative, adding that there are many other urine-based tests used in the diagnosis of bladder cancer, with similar diagnostic performance to ADXBLADDER. Another commentator said that the technology is a minor variation because it uses a different biomarker to other urine-based tests. The remaining commentator agreed that it is a minor variation to standard care but added that it wasn't a unique test or product. All commentators highlighted the relatively large number of competing technologies. Among those identified, urine cytology was regarded as the most common urine test for diagnosing bladder cancer. Nuclear matrix protein-22 test, UroVysion fluorescence in-situ hybridisation, ImmunoCyst and narrow band imaging during cystoscopy were also identified as competing technologies by commentators.

Potential patient impact

The benefits identified by the experts included: better triaging of high-risk patients based on its high negative predictive value; avoiding unnecessary invasive cystoscopy; improving the ease of sample collection and processing. One expert was not convinced by the claimed benefits of the technology over standard care, adding that initial cystoscopy would still be needed to assess other causes of haematuria, and that there is currently a lack of data to support the use of the ADXBLADDER test in the follow-up of people with bladder cancer. Commentators believed that the test could potentially be used in all patients with suspected bladder cancer, although 1 commentator said that in clinical practice the test is likely to only be used when cystoscopy does not offer diagnostic certainty. Patients needing monitoring after a diagnosis of bladder cancer were also identified by 1 of the commentators as those who could benefit from the technology. One commentator thought it was too early to say whether adopting the technology would change the current care pathway, while 1 commentator thought that it may be added as a follow-up option for patients but would not replace cystoscopy.

Potential system impact

The main system benefits identified by commentators were better triaging for some patients, potentially leading to a release of resource because of reduced cystoscopy, as well as the potential to improve follow-up in patients already diagnosed with bladder cancer. One commentator felt it was too early to say what the system benefits would be. All commentators agreed that ADXBLADDER would be an addition to standard care. Two of the commentators did not think ADXBLADDER would replace cytology in clinical practice; 1 said that the test is not sensitive or specific enough and 1 said that it did not provide more information than cytology which is a cheaper test. One commentator said it has the possibility to replace cytology if future studies can validate the findings from Dudderidge et al. (2018); that ADXBLADDER detects more cases of bladder cancers than cytology. One commentator said that use of ADXBLADDER would be cost-incurring because it would not replace cystoscopy, which is the costliest test. Two commentators said the technology would result in a minor increase in running costs but has the potential to be cost-saving overall if it is used in more selective cases and if it leads a reduction in the number of cystoscopies needed. One commentator thought that it would be cost-saving in the follow-up of patients with bladder cancer but only if it replaced the use of flexible cystoscopy in these patients.

Most commentators did not believe adopting the technology would have a substantial resource impact. Some commentators said that, because it is not a point-of-care test, it could potentially lead to more follow-up appointments or increase the time needed for processing or sending samples to a third party. No substantial changes to infrastructure or facilities were identified by any of the commentators, given that enzyme-linked immunosorbent assay testing is commonplace. One commentator thought that the test would be relatively easy to adopt with a simple learning curve, but would need further long-term and comparative data before a national rollout of the technology can be considered. None of the commentators were aware of any safety concerns or regulatory issues surrounding the technology.

General comments

One commentator noted that, although available, urine biomarker tests are not widely used across the NHS because of the marginal benefit they are thought to have over standard care such as cystoscopy and imaging. Apart from not being a point-of-care test, no substantial practical or usability issues were identified by the commentators. One commentator said that the data supporting the technology needs to be validated by independent studies assessing clinical utility and also highlighted the need for data comparing the clinical and cost effectiveness of ADXBLADDER to other competing technologies. One commentator said that the proposed patient population needs to be better defined. Another commentator highlighted their concern about the sensitivity of the product (76%), despite its high negative predictive value (97%).