An overview of the biomarker qualification process that provides information on current evidentiary considerations. It also provides new information on the evolution of the role that preclinical qualification plays in clinical qualification of biomarkers and the novel approaches that are being utilized to improve the process

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The BIC Review Tool is designed to improve communication, it allows an “inventors interview”-type of approach, in addition to being a checklist for Technology Transfer Offices and Researchers. It is designed to improve communication between the stakeholders involved in the commercialization process and to facilitate collaboration. The tool is therefore in a completely different format than the Biomarker Commercialization (BIC) Guide. All introductions and explanations are missing by intention since they can already be found in the BIC Guide, Best & Pitfall Practices handbook or the Regulatory Guide. 

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The Biomarker Commercialization (BIC) Guide supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention to a commercial product. It provides guidance through the technology readiness levels (TRL) and covers the clinical, regulatory, and business aspects of the commercialization process. The tasks are described and partially supported by useful, downloadable documents.

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This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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