Bladder Cancer the Clinical Challenge:

  • 150,000 bladder cancer diagnoses in EU per year
  • 65% recurrence rate, the highest of any malignancy 5
  • The gold-standard test, cystoscopy, is invasive, uncomfortable and expensive
  • 5 million haematuria patients undergo cystoscopy in Europe each year 1
  • Only 10% of haematuria patients are typically diagnosed with bladder cancer
  • White Light Cystoscopy is considered the gold standard test for bladder cancer 2
  • Upto 30% of bladder cancers missed at initial cystoscopy 3,4

MCM5 ELISA for Bladder Cancer

  • An easy-to-use, cost effective enzyme-linked immunosorbent assay (ELISA) format
  • Arquer Diagnostic’s first product and will be released for determination of MCM5 protein in human urine as an aid to the detection of bladder cancer
  • To be launched in H2 2017 in the EU, followed by other markets
  • Not currently approved for clinical use

MCM5 ELISA Excellent Performance Characteristics

In preliminary testing of 510 patients presenting with gross or micro haematuria at 3 leading UK hospitals the MCM5 ELISA has demonstrated the following performance characteristics;

MCM5 ELISA Superior Performance

Over a subset of 100 samples MCM5 ELISA demonstrated significantly greater sensitivity than established biomarker tests.

More information here

Contact me when the MCM5 ELISA is available


  1. Ferlay J et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries in 2012. Eur J Cancer 49(6), 1374-1403 (2013).
  2. Deshpande A et al. Bladder cancer diagnosis and management. GM, 06, 2014.
  3. Jocham D et al. Photodynamic diagnosis in urology: state-of-the-art. Eur Urol 53(6): 1138-48 (2008)
  4. Zhangqun Ye et al. A comparison of NBI and WLI cystoscopy in detecting non-muscle-invasive bladder cancer: A prospective, randomized and multi-center study. Sci Rep.; 5:10905 (2015)
  5. National Cancer Institute’s SEER database.