ADXBladder 510k Clinical Study to gain US FDA Clearance

The COVID-19 pandemic has created the need to manage cancer patients' backlog while reducing the unnecessary exposure of healthcare workers. For Symptomatic bladder cancer patients have not had the required tests to diagnose potential cancer, and patients who have previously had bladder cancer have been unable to undergo their t routine follow ups to check for recurrence.

Urology clinics are under pressure to see these patients with no tool to stratify which patients need to be seen as a priority.

Arquer have developed a test (ADXBLADDER) that can rule out the presence of a high-risk cancer with a 98.7-99.3% certainty. This innovative technology will enable urologists to stratify waiting lists allowing high-risk patients to be seen urgently, and providing low-risk patients with peace of mind on their condition.

This debt funding will support the continuation of this project, with 2 main aims. Part 1 aims to continue supporting the implementation of ADXBLADDER in UK; the traction gained in the last few months by the Clinical Specialists (which includes the recent implementation of the test within Bart's Trust) has encouraged the Company to continue with this endeavour.

Part 2 of the project will facilitate a 510K clinical study in the United States to gain FDA clearance allowing Arquer access to the largest bladder cancer market.