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Prostate cancer diagnostic assay based on protein kinase activity profiling in exosomes

Periodic Reporting for period 1 - ProCanEx (Prostate cancer diagnostic assay based on protein kinase activity profiling in exosomes)

Reporting period: 2015-06-01 to 2015-11-30

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.
1 Elaboration of the business plan was constructed to better understand the potential of the Kinasera technology to develop a prostate cancer screening or diagnostic assay as proposed in the Feasibility Study proposal. Business plan was compiled of the publicly available information but also using the advice given by mentors and other experienced businessmen in both public and private sector.
2 Market research was performed to estimate the current market situation. Market research indicated several companies developing a prostate cancer detection assay. We have defined four possible market segments, where our assay and detection probes could be developed as products.
3 In partner search we have established contacts with couple of larger companies to discuss joint platform development for cancer detection. In addition we have built contacts with private investor and mentor networks.
4 In intellectual property management the patent portfolio was evaluated and freedom to operate analysis performed.
5 We have estimated our funding needs for the projects in development.
6 A thorough R&D plan was constructed for further activities.
We believe one the most important part of the study was intellectual property evaluation. We found the field of prostate cancer diagnostics and screening to be well covered with patents for different technological solutions and several companies developing their assays. In addition we evaluated the freedom to construct our assay without infringing other patents. This knowledge gives us stronger position in all negotiations.

Market research has pointed out four major markets, where our technology is applicable. This gives us more opportunities to continue, as if one option fails we can continue with another.

Our partner search has created an opportunity for a joint development project with one of the market leaders in our segment. The joint collaboration takes the advantage of separate intellectual property items joining their advantages towards a single assay strengthening the position of each item alone.

Based on these results our assay has the potential to create a medical solution for the benefit of European economy. Cancer diagnostics is among the main concerns for healthcare as cancer is among the deadliest diseases, second only to heart diseases. A novel type of cancer assay would contribute to the sustainability of European health care systems in the face of rising medical expenditure for cancer and better detection results in early disease stages, where the chances of full recovery are good. Furthermore, overtreatment of some cancers have been proposed to cause more harm than good, thus timely and accurate detection of the disease is required.
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