News

Participation in the EU call INFRASTRUCTURE 2012.1.1.5

EATRIS wants to forward the process of integration and to accelerate the building of European translational research infrastructure
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A leap forward in the effectiveness of biomedical research - for better patient outcomes

EATRIS marks official start to developing Europe’s translational research of the future
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Biomarker

Biomarkers

EATRIS biomarker centres have a range of expertise in biomarker development and the required infrastructure to define and prepare both existing and new services. EATRIS provides infrastructure and service capabilities that can significantly improve the currently dismal rate by which 100s of academic biomarker discoveries published each year get translated into approved diagnostic products. EATRIS Biomarkers product group offers a standardized platform for European biomarker development, particularly in areas that are becoming increasingly important, but are underdeveloped by the industry, such as multiplexed and tissue- and imaging-based, morphologically oriented biomarker development. EATRIS also offers translational, standardized access to unique capabilities (patient materials, biobanks, and clinical data) that exist in the participating centres and academia in general. These are important for private sector users with diagnostic development pipelines. In particular, the use of standardized biobanks is facilitated by collaboration with the European-wide Biobanking infrastructure BBMRI. Furthermore, a key issue is data sharing, to facilitate multi-centre trials within the EATRIS network. This is accomplished via an IT infrastructure and web microscopy, distributed to key EATRIS parties for joint standardized development projects on biomarkers. Users may make use of the whole biomarker pipeline, or some defined key elements.

Depending on the nature of biomarker and the starting point, the output of the EATRIS biomarker effort is:

  • Identification of the critical path required to advance a new biomarker towards a product;
  • Validation of the biomarker in independent sample cohorts, initial assessment of the sensitivity, specificity, with standardized technologies;
  •  Prototype diagnostic assay development, standardisation and optimisation of the quality control parameters;
  • Validation of the prototype diagnostic assay and development of a commercial plan, including industrial participation and regulatory steps required.