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Validation Manager - A disruptive turnkey solution for diagnostic test validations

Objective

The need for fast and accurate diagnostics in laboratories is an exceedingly important global issue. It is a mandatory requirement by regulators that the performance of any new clinical diagnostics test must be thoroughly demonstrated, i.e. validated before it can be sold by the diagnostics companies, or taken in use by laboratories. Organizations may easily waste on average 100 000€ a year for validations, which could be saved.

Finbiosoft (FBS) has introduced a unique and disruptive cloud-based (SaaS) software, Validation Manager™, which makes validation of diagnostic tests according to requirements truly easy and is able to cut down even 95% of the time needed for validations. The software enables i) diagnostic companies to save dramatically time and money to reach markets faster, allowing them to sell more, and ii) laboratories to be able to cost effectively evaluate and take into use the best available diagnostics. The estimated market potential globally is 750 M€.

Finbiosoft's ambition is to revolutionize industry practices and make its solution a de facto tool for managing validations globally in all diagnostics segments. FBS is the only player on the market offering a full turnkey solution, and holds a unique opportunity to grab the global leadership position in diagnostics validations.

In the project, FBS will assess the market potential and arising challenges when expanding from the first targeted segment, molecular diagnostics, to other segments like clinical chemistry. Upon completion of the project, FBS deeply understands requirements to commercialize its product to new segments regarding both technical and economic aspects with a plan to achieve the desired de facto status. The outcome is comprehensive business plan and knowledge of the full potential for the solution in Europe with a detailed road map and go-to-market model, crucial to provide direction to the next phase of development and the planned Horizon 2020 SME phase II application.

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

FINBIOSOFT OY
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
LINNOITUSTIE 4A
02600 ESPOO
Finland

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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
Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa
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.

€ 71 429,00
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