Start-up company UroSens based in the northeast of England has developed a new diagnostic urine based ELISA test to detect early signs of bladder cancer. Bladder cancer is the seventh most common cancer in the UK and affects approximately 11,000 new patients a year, according to Cancer Research UK, 2011. There are an estimated half a million people living with this condition in the US. The majority of these patients will present to their doctor with haematuria (blood in the urine) amongst other symptoms. Up until now the diagnostic test for bladder cancer has been that of a painful cystoscopy whereby a catheter is inserted into the bladder through the ureter or urethra in order to examine the bladder. Current figures suggest that up to 1 million patients present at their health practitioner in the US and Europe each year, potentially meaning a high number of procedures undertaken in order to eliminate a cancer diagnosis.UroSens, headed up by CEO Dr Ian Campbell (PhD) have designed a new diagnostic ELISA based test which could potentially prevent unnecessary examinations by detecting a cancer bio-marker found in the urine of patients presenting with haematuria. Having been in development since 2005, the test is based on the fact that urine samples from healthy individuals should not be able to grow dividing cells such as those found in malignant tumours. The test measures the presence of these cells by detecting a minichromosome maintenance (MCM) protein named MCM5. The MCM5 ELISA test measures the presence of dividing cells in the urine sample and can produce a diagnostic result in approximately 150 minutes.The miniaturisation and condensation of the diagnostic process has allowed UroSens to create a palm-sized diagnostic test strip which has been shown to provide reliable and repeatable results which were previously only achievable through ‘a very academic and long-winded experimental process which took three days and involved extreme temperatures’ according to Campbell. This process has also magnified the sensitivity of the test 100-fold.In January 2015, the company, which also has a base in Cambridge UK, announced that it had generated £2 million of investment in order to be able to move forward with their device and commercialise it as a diagnostic test in both bladder and prostate cancer. With an estimated 40,000 new cases of prostate cancer detected in the UK alone each year this has the potential to drastically reduce the number of unnecessary invasive procedures in these patients and greatly improve the standard of care. With the 510K clearance estimated to be approved in the second quarter of 2016 this device is not too far from being able to achieve market entry.