Periodic Reporting for period 1 - OsteomiR (OsteomiR-Test – An In-Vitro Test for the Diagnosis of Osteoporosis and associated Fracture Risk) Reporting period: 2015-07-01 to 2015-12-31 Summary of the context and overall objectives of the project TAmiRNA aims to commercialize an in-vitro diagnostic test that is intended to predict fracture-risk in case of osteoporosis.Osteoporosis is a chronic skeletal disease characterized by systemic loss of bone strength and consequently high incidence of bone fractures. Osteoporotic fractures constitute one of the most common and costly health problems in the European Union. Effective fracture prevention can be achieved through exercise, diet and drug treatment, but depends on reliable early prognosis of fracture risk. The gold-standard technology is bone densitometry, which fails to detect every second high-risk patient.The OsteomiR-Test measures a proprietary combination of circulating microRNAs from standard blood samples. The analyzed microRNAs provide a direct readout of bone metabolism, stress and biological age, and have been demonstrated to have a strong association with fracture-risk. It is a robust, easy-to-use test with good scalability. In order to commercialize the OsteomiR-Test, a detailed assessment of a market entry strategy is required.Therefore, the objectives for this project were toi. Perform a cost-effectiveness analysisii. Identify suitable manufacturing partnersiii. Develop CE-registration roadmapiv. Assess freedom-to-operate Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Task 1: We have entered a collaboration with the Institute for Pharmaeconomical Research for the development of health economic models to assess the socio-economic impact of the OsteomiR test in the Austrian population. Cost-Utility analysis together with a sensitivity analysis were performed to estimate the impact of improved early diagnosis on quality-adjusted life-years (QALY).Task 2: We have entered an agreement with contract-manufacturing organization for the design and production of quantitative PCR assays for targeted microRNA analysis from liquid biopsies.Task 3: Together with Partners the intended-use of the OsteomiR test was defined. Based on this definition, the respective requirements of the IVD-Directive EC 98/79/EC were identified and a roadmap for the submission process was generated.Task 4: The OsteomiR test design was developed together with a contract-manufacturing organization. Freedom-to-operate for commercial use of the OsteomiR test was assessed together in respect to technology related IP as well as method-for-use related IP. 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) This feasibility study has significantly helped to assess the commercial viability of the OsteomiR test and to define a development and commercialization strategy: i) improving early diagnosis of osteoporosis was demonstrated to have a cost-effective impact on health of post-menopausal women, ii) a roadmap for test manufacturing and CE-registration has been developed, which is based on technologies for which a freedom-to-operate has been secured. These are important achievements for successfully translating the goals of our business plan for the OsteomiR test. The OsteomiR Test Plate The Team behind the OsteomiR Test The OsteomiR test can help to decrease fracture incidence and increase Quality of Life
