Laboratory / Urology
A rapid, innovative, non-invasive urine test for the diagnosis
and follow-up of bladder cancer.
Rapid, easy-to-use
ELISA test
Utilizes patented MCM5 biomarkers
Breakthrough NPV and High Sensitivity
ADXBLADDER is a highly accurate, simple, fast and painless urine testing kit which can rule out bladder cancer with up to 99% accuracy. The UK-made, game-changing test is set to revolutionise how patients with bladder cancer are diagnosed and monitored.
It will reduce the need to undergo unnecessary, invasive and often painful testing and help speed up the diagnosis of those at highest risk of having the disease. 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 blood in the urine (visible or invisible haematuria). Additional benefits include that the test uses a standard ELISA technology, readily available in every hospital laboratory, requires a minimum of 10ml of urine and takes just three hours to achieve a “yes/no” result.
The results from the two largest prospective, blind, and multicentre clinical trials undertaken with the MCM5 biomarkers are reflective of real-life patient experiences, consistently demonstrating that ADXBLADDER is highly accurate and outperforms cytology.
Roupret (full study results)
https://www.auajournals.org/doi/10.1097/JU.0000000000001084
Gontero (comparison with cytology)
https://bjui-journals.onlinelibrary.wiley.com/doi/abs/10.1111/bju.15194
Where does ADXBLADDER fit on the patient pathway?
How the MCM5 Technology Works?
Arquer tests use a patented technology to detect a protein produced by the expression of the MCM5 (Minichromosome Maintenance Complex Component 5) gene in urine, which can rule out the presence of bladder cancer.
Proliferative cells express MCM5 protein at a high level, whereas differentiated quiescent cells and senescent cells lack such expression.
In contrast, both invasive and non-invasive urothelial carcinomas express MCM5 in all layers of the urothelium, including superficial epithelial cells. This results in the shedding of cancer cells expressing MCM5 into the urine.
Therefore, when a tumour is present in the bladder, the MCM5 biomarkers will be present in the urine and can be detected by Arquer technology.
ADXBLADDER is the first of Arquer’s MCM5 tests to be released as a CE marked bladder cancer test. Arquer is also currently testing the technology in prostate and endometrial cancers.
The ADXBLADDER ELISA Kit
