bLadder cAncer URine cEll aNalysis

Bladder cancer is the 4th most common cancer in men and the 7th in women, with 330,000- 380,000 new cases annually worldwide or more than 150,000 in Europe and is one of the most expensive cancers to manage. Bladder cancer incidence is strongly related to age, with the highest incidence rates being in older men and women. Cystoscopy/cystoscopic biopsy remains the current gold standard diagnostic and monitoring tool. This procedure is highly invasive and expensive - costing up to €1200 per test - and has been reported to miss in the region of 25% of all bladder tumours. As an adjunct to cystoscopy, urine cytology is routinely carried out globally but its deficiencies in terms of poor cancer detection (low sensitivity) are well recognised and reported. The overall objective of the LAUREN project is to provide a commercial non-invasive in vitro diagnostic that will significantly reduce the management cost of caring for bladder cancer patients, whilst at the same time improving patient comfort and reducing morbidity associated with current invasive procedures. The specific diagnostic is based on the MCM2 + Immunofluorescence biomarker for bladder cancer cells found in urine.The scope of the project is to complete the final development, validation and regulatory activities required to prepare a novel the new diagnostic for the market.The objectives of the project are to:PO1 Clinically validate the biomarkers including the addition of Immuno Fluorescence PO2 Complete development of and validate a single use cell collection device,PO3 Validate the cell recognition software for regulatory acceptancePO4 Validate the software of an automated slide analysis system.PO5 Prepare a complete evidence package to support obtaining a CE Mark and FDA approval for commercialisation