New non-invasive urine test for bladder cancer

A new non-invasive urine test for bladder cancer could reduce cystoscopy and CT scans, according to new trial results.

The ADXBLADDER test, launched at the 37th Société Internationale D’Urologie (SIU) meeting in Lisbon, Portugal, October 19-22, 2017, was shown to have 95% sensitivity for higher-risk cancers and a negative predictive value (NPV) greater than 97%.

Between August 2016 and February 2017, 577 patients attending diagnostic haematuria clinics at six UK centres underwent ADXBLADDER testing, with results then compared to the diagnostic benchmark of combined cystoscopy, ultrasound and CT scanning.

The results found the overall sensitivity of the test was 76% (high risk 92%; muscle invasive group 100%; intermediate risk 75%; low risk 50%); the overall specificity was 69%; and the NPV 97%.

‘Our study demonstrates ADXBLADDER has one of the highest sensitivities and negative predictive values of any urine test for bladder cancer diagnosis,’ said Mr Stuart McCracken, the study presenter, from Sunderland Royal Hospital. The test uses standard ELISA methodology to measure levels of MCM5, a protein marker of replicating cells, or cells which have the capability to replicate.

 ‘What’s really important is the test achieved very good sensitivity in high-risk patients and those with muscle invasive disease, where cancer is likely to spread quickly, and prognosis is much poorer,’ said Mr McCracken.

Considering how the new test might be integrated into current diagnostic pathways, Mr Tim Dudderidge, a urology surgeon from Southampton University Hospital, suggested that for low-risk patients with non-visible haematuria the test could be combined with ultrasound, and for high risk patients with visible haematuria the test could be combined with ultrasound and cystoscopy. ‘This could lead to reductions in cystoscopy and CT scans,’ he said.

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