ADXBLADDER clinical data

Arquer’s robust clinical development programme demonstrates that ADXBLADDER has one of the highest sensitivities and negative predictive values (NPV) of any urine test for bladder cancer diagnosis and recurrence monitoring.

It offers innovative features such as the result being unaffected by urinary tract infections, inflammation or the presence of visible blood in the urine.  Additional benefits include that the test uses standard ELISA methods, available in almost every hospital laboratory, requires only 10mls of urine and takes just three hours to achieve a “yes/no” result.

The results from the two largest clinical trials undertaken with the MCM5 biomarker are reflective of real-life patient experiences consistently demonstrating that ADXBLADDER is highly accurate and outperforms cytology.

A UK multi-centric study examined how effective ADXBLADDER is at diagnosing bladder cancer in patients with haematuria (blood in the urine) compared to cystoscopy, imaging and biopsy. 1

  • 856 patients were enrolled into a blinded prospective study conducted at seven leading UK centres
  • The trial included patients presenting with haematuria and/or lower urinary tract symptoms
  • ADXBLADDER was compared to patients’ cystoscopy, imaging and biopsy results

A large multi-centric European study of bladder cancer patients evaluated the performance of
ADXBLADDER compared to cystoscopy, cytology and pathology.2,3,4

  • 1,700 patients enrolled into the blinded prospective study conducted at 21 leading European centres
  • The trial included patients in the first two years of follow up after a primary or recurrent bladder tumour
  • ADXBLADDER was compared to cystoscopy, cytology and pathology

Technical Information is available here

In addition, to these two recent studies Arquer has drawn on 20 years of scientific research to perfect a diagnostic product which detects cancer with confidence and reliability. More information about these studies can be found in the references

References

  1. Dudderidge T, et al. A Novel, non-invasive Test Enabling Bladder Cancer Detection in Urine Sediment of Patients Presenting with Haematuria—A Prospective Multicentre Performance Evaluation of ADXBLADDER. Eur Urol Oncol (2019), https://doi.org/10.1016/j.euo.2019.06.006
  2. Roupret M, Gontero P, McCracken SRC, et al. Diagnostic Accuracy of MCM5 for the Detection of Recurrence in Non Muscle Invasive Bladder Cancer Follow up: A Blinded, Prospective Cohort, Multicentric European Study [published online ahead of print, 2020 Apr 21]. J Urol. 2020;101097JU0000000000001084. doi:10.1097/JU.0000000000001084
  3. Roupret M. et al. , Diagnostic performance of MCM5 testing in the diagnosis of recurrent bladder cancer: Results from a large prospective, blinded, multicentric European study
    Eur Urol Open Sci 2020;19(Suppl 2):e1353
  4. Gonter P. et al., Evaluation of ADXBLADDER and cytology performance in the follow up of NMIBC: A blinded prospective multicentric study
    Eur Urol Open Sci 2020;19(Suppl 2):e1366

Other relevant MCM5 Publications

  • Stoeber K, Halsall I, Freeman A, et al. Immunoassay for urothelial cancers that detects DNA replication protein Mcm5 in urine. Lancet. 1999;354(9189):1524‐1525. doi:10.1016/S0140-6736(99)04265-8
  • Williams GH, Swinn R, Prevost AT, et al. Diagnosis of oesophageal cancer by detection of minichromosome maintenance 5 protein in gastric aspirates. Br J Cancer. 2004;91(4):714‐719. doi:10.1038/sj.bjc.6602028
  •  Davies RJ, Freeman A, Morris LS, et al. Analysis of minichromosome maintenance proteins as a novel method for detection of colorectal cancer in stool. Lancet. 2002;359(9321):1917‐1919. doi:10.1016/S0140-6736(02)08739-1
  •  Scott IS, Odell E, Chatrath P, et al. A minimally invasive immunocytochemical approach to early detection of oral squamous cell carcinoma and dysplasia. Br J Cancer. 2006;94(8):1170‐1175. doi:10.1038/sj.bjc.6603066
  • Ayaru L, Stoeber K, Webster GJ, et al. Diagnosis of pancreaticobiliary malignancy by detection of minichromosome maintenance protein 5 in bile aspirates. Br J Cancer. 2008;98(9):1548‐1554. doi:10.1038/sj.bjc.6604342
  •  Dudderidge TJ, Kelly JD, Wollenschlaeger A, et al. Diagnosis of prostate cancer by detection of minichromosome maintenance 5 protein in urine sediments. Br J Cancer. 2010;103(5):701‐707. doi:10.1038/sj.bjc.6605785

Study sites