Progress in personalised medicine is limited by missing pan-European and international standard documents and insufficient guidelines for pre-analytical workflows. This situation does currently not sufficiently prevent using compromised patients’ samples with post collection changes in cellular and extracellular biomolecules’ profiles, thus often making diagnostic test results unreliable or even impossible. To tackle this, SPIDA4P plans to initiate, develop and implement a comprehensive portfolio of an additional 14 pan-European pre-analytical CEN/TS and ISO/IS documents, addressing the important pre-analytical workflows applied to personalized medicine.

First studies had been already undertaken by the first SPIDIA programme to determine the important influencing pre-analytical factors in regard to blood, plasma, urine and tissue samples. The SPIDIA research and other studies‘ results were provided to the CEN/Technical Commitee 140 for “In vitro medical devices” (CEN/TC 140) as the basis for developing the first CEN Technical Specifications (CEN/TS) for pre-analytical workflows. Most of them meanwhile further progressed to ISO standards (see above)