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Predictive in vitro diagnostics test for individualized tailoring of chemotherapy in primary breast cancer

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)

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Programme(s)

Multi-annual funding programmes that define the EU’s priorities for research and innovation.

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-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.

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

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Coordinator

SIVIDON DIAGNOSTICS GMBH
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.

€ 50 000,00
Address
NATTERMANNALLEE 1 GEB S19
50829 KOLN
Germany

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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
Nordrhein-Westfalen Köln Köln, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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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.

€ 71 429,00
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