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RABIOPRED - Clinical validation of BIOmarker assay to PREDict treatment response in Rheumatoid Arthritis (RA) patients

Objective

The aim of the RABIOPRED project is to take the final steps to bring an innovative set of biomarkers that is able to predict response to treatment with TNF-α inhibitors in Rheumatoid Arthritis (RA) to the market and clinical practice.

Millions of RA patients are treated with TNF-α inhibiting agents, currently one of the main second-line treatment strategies for RA. These expensive biological RA therapies represent a multibillion market. However, the TNF-α inhibiting agents are not effective in 30-40% of the patients. Clinicians are currently unable to predict the response to this treatment beforehand. The ability to predict response to treatment would greatly improve clinical decision-making, improve health outcomes for RA patients, and contribute to cost reduction and sustainability of the health care system.

The RABIOPRED assay is based on a novel gene expression signature and a predictive model, that have been identified and developed by TcLand Expression SA and that have been patented. Proof-of-concept has already been obtained for the prototype biomarker assay. The analytical validation and clinical performance evaluation of the RABIOPRED assay in the current project are the final development steps towards market introduction and clinical application. At the end of this 3.5 year project, a validated and CE registered IVD biomarker assay will be available that is ready for clinical application, initial market introduction and further commercialization and implementation.

TcLand Expression SA is a French SME developing biomarkers for personalized medicine and companion diagnostics in immune mediated disorders. TcLand focusses on development and validation of noninvasive multi-gene molecular diagnostic blood tests. TcLand is embedded in an international network of collaborating pharmaceutical companies and clinical centers throughout Europe, facilitating clinical performance evaluation and enhancing subsequent market uptake of novel biomarkers assays.

Fields of science (EuroSciVoc)

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Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

SME-2 - SME instrument phase 2

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-SMEInst-2014-2015

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Coordinator

FIRALIS MOLECULAR PRECISION SA
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 4 364 000,00
Address
17 RUE DU FORT
68330 Huningue
France

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Grand Est Alsace Haut-Rhin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 4 995 250,00

Participants (1)

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