DIRECT - Innovative Medicines Initiative:
DIabetes REsearCh on patient straTification

Work Package 6 (WP6):
Assay development and validation

Studies of WP6 will analyze biomarkers that arise from WPs 2 to 5 for applicability to development of high-throughput, high-resolution assay, and develop into assays where appropriate. The analyses will be first checked for quality aspects before going on to validation in DIRECT patient samples. Validation will be done in cohorts of type 2 diabetes patients existing within the consortium and in prospective trial data available to EFPIA partners.


In assay development, we will explore novel technologies allowing multiplexing of biomarkers, their quantification and quality assurance. Biomarker assay development and validation will include immunoassays, assays for genotyping and sequencing analytics of biomarkers, metabolomic and lipidomic assays, and antibody-based proteomics assays.


All new sample collection and reuse of existing samples will be carried out in conformity with all necessary ethical, legal and regulatory requirements in consultation with WP9. Furthermore, work on biomarker validation and the analyses in clinical trials (WP7 and WP8) will be in line with biomarker qualification guidelines and with close involvement of the EMA.



Participants
  • University of Dundee
  • Helmholtz Zentrum München – Deutsches Forschungszentrum für Gesundheit und Umwelt GmbH
  • Université de Genève
  • Kungliga Tekniska Högskolan