ADXBLADDER: A Novel Non-Invasive Aid for Bladder Cancer Monitoring

The innovative Arquer Diagnostic urine test for bladder cancer adds recurrence monitoring to the approved indications

Sunderland, January 22nd 2019. After succesfully launching ADXBLADDER urine test for the detection of bladder cancer, Arquer Diagnostics announces today the addition of bladder cancer recurrence monitoring as a new indication for use.
“The clinical data supporting this new indication are very consistent with the results observed in all our clinical studies” observes Nadia Whittley, CEO of Arquer Diagnostics. “The reproducibility of the results on a large patient population is a strong indicator of the effectiveness of this diagnostic test. We are now completing the 2000 patients multicentric European study, and the high sensitivity, especially in high grade tumors, coupled with unprecedented negative predicted value continue to be observed, giving our clinical study investigators high confidence in the performance of the test.”

ADXBLADDER measures levels of the MCM5 protein, which is a marker of cells that are replicating, or still have the capability to replicate (i.e. are not terminally differentiated). Such cells are normally only found in basal layers of the epithelium, but when a mass of replicating cells is present (as occurs in bladder cancer), MCM5 cells are shed into bodily fluids. MCM5 in the urine is indicative of undifferentiated cells in an inappropriate location. Detection utilizes standard Enzyme Linked ImmunoSorbent Assay (ELISA) methodology, using mouse monoclonal antibodies to identify MCM5 antigens.

ADXBLADDER is clearly performing consistently across a large population and is demonstrating very exciting results in the detection of recurrent disease- particularly high grade tumours that are at high risk of progression.” said Prof Palou , PI of the ongoing European Study from Fundacio Puigvert Barcelona.

ADXBLADDER is available in all European countries; for more information consult the Arquer Diagnostics web site.

For further information:

Corporate & Clinical Enquiries:

Arquer Diagnostics +44 (0) 191 516 6765
info@arquerdx.com
www.arquerdx.com

About Arquer Diagnostics Ltd

ADXBLADDER, a non-invasive bladder cancer diagnostic test, is the first product to be launched by Arquer Diagnostics. Arquer Diagnostics, launched in 2015, is a company based on the development of non-invasive cancer diagnostic tests using the MCM5 (minichromosome maintenance protein) platform. The mission of Arquer Diagnostics is to deliver accurate, rapid, minimally invasive oncology diagnostic products. Arquer Diagnostics, who are headquartered in Sunderland, United Kingdom, are supported by an international medical advisory board. ADXBLADDER is currently commercialized in Europe and will be further released to other regions in 2019.