Objective
SIVIDON established a prototype diagnostic assay - the ChemoPredict test - to stratify high-risk breast cancer patients and to help in deciding whether to treat the patient with standard anthracycline-based chemotherapy without taxane or taxane-containing regimens. ChemoPredict was clinically validated in a large clinical phase III trial (FinHer) with 919 patients using a prospective-retrospective approach. The existing training and validation studies of ChemoPredict provided evidence that the assay can reduce the number of taxane-based chemotherapies within the test’s target group by about 50% without impairment of outcome of the patients. Thus, the use of the assay in breast cancer care will result in a more specific use of taxanes and a reduction of overtreatment thus avoiding serious side effects in patients and saving costs for the health care system.
SIVIDON’s aim for the overall innovation project is to extend clinical and analytical validation data, to develop ChemoPredict as a CE-marked IVD test according to IVD directive 98/79/EC and to bring this test as a tool for personalized medicine into the European market.
The objective of the feasibility study is to generate an elaborated business plan including detailed market analyses for ChemoPredict. Several key opinion leaders will be interviewed to get their perspective on the application, the inclusion into clinical guidelines and market entrance of the innovative predictive test. Phase I will be also used to decide on an extended clinical validation strategy to ensure that the ChemoPredict assay exhibits the highest clinical evidence level. Advisory boards will be initiated, opportunities for entering clinical guidelines will be judged and reimbursement concepts in European countries will be assessed. Regulatory issues will be comprehensively evaluated to decide on the best product development strategy, a detailed product development plan will be generated and phase 0 development strategies will be started.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine oncology breast cancer
- medical and health sciences health sciences personalized medicine
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
MAIN PROGRAMME
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H2020-EU.3.1.3. - Treating and managing disease
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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.
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.
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-1 - SME instrument phase 1
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
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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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.
50829 KOLN
Germany
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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.