OsteomiR-Test – An In-Vitro Test for the Diagnosis of Osteoporosis and associated Fracture Risk

Informations projet

OsteomiR

N° de convention de subvention: 683435

DOI

10.3030/683435

Projet clôturé

Date de signature de la CE 2 Juin 2015

Date de début 1 Juillet 2015

Date de fin 31 Decembre 2015

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

TAMIRNA GMBH
Austria

Periodic Reporting for period 1 - OsteomiR (OsteomiR-Test – An In-Vitro Test for the Diagnosis of Osteoporosis and associated Fracture Risk)

Période du rapport: 2015-07-01 au 2015-12-31

Résumé du contexte et des objectifs généraux du projet

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 to

i. Perform a cost-effectiveness analysis
ii. Identify suitable manufacturing partners
iii. Develop CE-registration roadmap
iv. Assess freedom-to-operate

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

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.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

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