Periodic Reporting for period 1 - BLACANDI (BLACANDI can improve life quality and cut cost of diagnosing and managing bladder cancer in half) Reporting period: 2015-07-01 to 2015-12-31 Summary of the context and overall objectives of the project BLACANDI is based on a successfully concluded small fully randomized blinded clinical study of 500 patients presenting with blood in the urine meeting its end-point of a sensitivity of +90%. The Horizon2020 phase I feasibility study identified no competitors that could match this end-point; however, a number of competing approaches was identified, which will supplement cytology rather than substitute cystoscopy - and as a result increase cost of care. Implementation into standard of care would require a clinical study of 4000 patients representing with blood in the urine’ which is planned as the phase II of the BLACANDI Horizon2020 project.The overall objective of the Bladder Cancer Diagnostic “BLACANDI” project (Phase I + II) is to eliminate or dramatically reduce the use of cystoscopy in the diagnosis and follow-up of bladder cancer patients, and thereby reduce the cost of care of bladder cancer. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far The clinical study performed meet the end-point of +90% sensitivity. All task associated with moving the BLACANDI solution to market through regulatory, IP, engagement with Key Opinion Leaders, clinical trail planning and commercialization plan was executed. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Many academic institutions and commercial companies has identified many different markers for bladder cancers, however so far all single or combination of markers have failed to match the performance of cystoscopy and for that reason implementation of those markers will only increase cost of care.Bladder cancer is one of the most expensive cancers to manage. Only 1 out of 10 patients presenting with blood in the urine has bladder cancer; however, in the absence of better assays capable of identifying more than 90% of all cancer cases, cystoscopy has remained the standard of care. In Europe €1.8 billion/year is spend on cytoscopy just for diagnosing the disease. Due to the risk of recurrence all patients undergo routine cystoscopy often several times/year. Managing recurrence is estimated to cost an additional €1.8 billion/year. Implementing the BLACANDI system instead of cystoscopy could cut the cost of diagnosing and managing bladder cancer in half. figure.jpg
