The objective of the innovation project is the development of a novel biomarker-based non-invasive assay for prostate cancer (PCa) detection. The assay is built on an innovative technological platform based on quantitative profiling of protein kinases on circulating exosomes. Project development plan comprises validation of optimised assay prototypes aimed at definition of their diagnostic indication. Overall, our platform addresses medical, social and pharmaceutical needs and market niches.
417 000 Europeans were diagnosed with PCa in 2012, which makes PCa the most frequent cancer amongst European men (about 12% of new cases of all cancers). In the same year, 92 200 European men were estimated to die from the disease (5% of all cancer deaths in Europe). The diagnosis and screening segment of global market of PCa totalled 12 billion USD in 2012 and will reach 17.4 billion USD in 2017.
The PCa diagnostics market is still mainly covered by different formats of the Prostate-Specific Antigen (PSA) test, the practicality of which is highly debated.
Currently, the most often used prostate cancer screening tests are based on measurement of PSA concentration in blood. More than 45 million PSA tests are performed annually worldwide, while more than 9 million of those are positive, with around 70% false positives. PSA has an overall sensitivity of 85% but only 25%-35% specificity and cannot be used as a standalone diagnostic tool. The low specificity of the test means a high number of false positives, leading to unnecessary and painful procedures (biopsies, treatment, etc). It has been estimated that for every 47 men who had their prostates removed, a single cancer death was avoided. It is estimated that the total savings from better diagnostics of PCa could reduce medical costs by more than 30% or $ 4.5bn in the USA only just by reducing the number of unneeded biopsies
Based on the above, there is a clear market need for a reliable PCa diagnostic test. It is estimated that a test with the same sensitivity than PSA but better specificity could reduce medical costs by $ 4.5bn a year in US alone.
We will develop an innovative, non-invasive, precise, highly reliable and cost-effective in vitro diagnostic (IVD) test, for PCa diagnostics.
The overall objectives of the Project were to estimate the Market situation for the prostate cancer assay in development and compile a business plan. In addition, freedom to operate analysis and evaluation of patent portfolio was carried out. We searched for partners for the assay development and investors and mentors. Also, a detailed research plan was composed.
