This website offers a set of free biomarker commercialization tools to help researchers, small and medium sized companies (SMEs), and technology transfer offices (TTOs) tackle the highly regulated and interdisciplinary landscape of in-vitro diagnostics applicable biomarkers, i.e., markers intended to provide information on the health status of a person.

The tools guide researchers and product developers through the technology readiness levels (TRL) and remind about the technical, regulatory, and business aspects of the innovation process.

What are TRLs?

The Technology Readiness Level (TRL) scale is the most widely used tool for maturity assessment. It allows a consistent comparison of maturity between different types of technologies.

The TRL concept was originally developed by the NASA - National Aeronautics and Space Administration to support the development of space technologies and allow for more effective assessment of and better communication on the maturity of new technologies.

What tools are included in the Biomarker Commercialization Toolset?

• The BIC Biomarker Commercialization Guide provides guidance throughout the biomarker development process from the discovery to the launch of the product. It is a tool to monitor the progress of the biomarker development process actively.
• The BIC Best Practice Handbook offers hints and tips on e.g., commercialization aspects, intellectual property rights, business models and legal viewpoints for different phases of biomarker discovery and development.
• The BIC ReviewTool is a tool for choosing the most innovative/ commercializable biomarker projects. It is a fill-in form for following the progress of a project.
• The BIC Regulatory Tools were created to extend, organize, and systematize knowledge around regulatory affairs. They aim to support stakeholders who participate in the process of placing IVD biomarker products on the market. The toolset includes a BIC IVD Regulatory Guide and a BIC IVD Regulatory Roadmap.
• The Educational Toolbox is a collection of different kinds of information that are either directly related to BIC tools or generally related to the commercialization of biomarkers. Its purpose is to give a quick introduction to BIC tools as well as deeper information about various topics of biomarker commercialization.

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Risk Disclosure Statement

The tools are only intended as guidance and should be considered advice only. The tools have been compiled from a wide variety of sources and cannot be claimed to be complete. None of the authors, contributors, administrators, or anyone else connected with the BIC Project or the BIC BRIDGE project and this website in any way whatsoever, can be responsible for your use of the information contained in or linked from these web pages. Each new discovery or development is individual; therefore, we recommend getting in contact with specialists and experts in the field.

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You can access the tools through the menu on top or by choosing from the list below: