SPIDIA for Personalized Medicine - Standardisation of generic Pre-analytical procedures for In-vitro DIAgnostics for Personalized Medicine

SPIDIA4P is a 48-month project funded by the European Commission under de H2020 program that brings together key experts of 19 stakeholder organisations, with the needed critical mass in knowledge on pre-analytical and analytical procedures, on European and international standardisation organisations’ processes (CEN and ISO), external quality assurance, quality management, ethics and regulatory demands.

SPIDIA4P will work via a coordination action with other large initiatives in the field as well as with major stakeholder organisations. All together, these highly experienced partners plan to carefully develop and implement a comprehensive portfolio of 20 pan-European pre-analytical CEN/Technical Specifications and ISO/International Standards, addressing the important pre-analytical workflows applied to personalised medicine. These will also be applicable to biomarker discovery, development and validation as well as to biobanks. Corresponding External Quality Assurance (EQA) Schemes will be developed and implemented as well, aiming to survey the resulting quality of samples and diagnostic practice. SPIDIA4P will ensure training, education, and counselling as additional major foci of the project.

The SPIDIA4P consortium will closely coordinate with large European public research consortia to obtain access to research and validation studies data, serving as evidence for the new standards developments for achieving improvements of diagnosis, patient stratification and prognosis of disease outcome.

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Uwe Oelmüller