Standardisation of generic Pre-analytical Procedures for In vitro Diagnostics for Personalised Medicine

Molecular in vitro diagnostics and biomedical research have allowed great progress in personalised medicine but further progress is limited by insufficient guidelines for pre-analytical workflow steps (sample collection, preservation, storage, transport, processing etc.) as well as by insufficient quality assurance of diagnostic practice. This allows using compromised patients’ samples with post collection changes in cellular and extra-cellular biomolecules’ profiles thus often making diagnostic test results unreliable or even impossible.

To tackle this, SPIDA4P aims to generate and implement a comprehensive portfolio of 22 pre-analytical CEN Technical Specifications and ISO International Standards, addressing the important pre-analytical workflows applied to personalized medicine. These will also 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 stakeholder organisations involvements as well as training, education, and counselling as additional major foci of the project.

SPIDIA4P consists of 19 highly experienced partners and 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 and achieved improvements of diagnosis, patient stratification and prognosis of disease outcome.

Project duration

01.01.2017 – 01.01.2020

Project partners

  • QIAGEN GmbH, Deutschland (Projektkoordinator)
  •  LGC Ltd., UK
  • Technische Universität München, Deutschland
  • DIN Deutsches Institut für Normung e.V., Deutschland
  • PreAnalytix GmbH, Schweiz
  • Inivata Ltd., UK
  • Cambridge Protein Arrays Ltd., UK
  • TATAA Biocenter AB, Schweden
  • Università degli Studi di Firenze, Italien
  • Consorzio Interuniversitario Risonanze Magnetiche di Metallo Proteine, Italien
  • Università degli Studi di Trieste, Italien
  • Università degli Studi di Torino, Italien
  • Biobanks and Biomolecular Resources Research Infrastructure Consortium (BBMRI-ERIC), Österreich
  • Luxembourg Institute of Health, Luxemburg
  • Medizinische Universitat Graz, Österreich
  • Institut national de la santé et de la recherche médicale, Frankreich
  • Erasmus universitair medisch centrum Rotterdam, Niederlande
  • Fundació Centre de Regulació Genòmica, Spanien
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Italien

Project website


Project funding

The project SPIDIA4P is funded by the European Commission under the Horizon 2020 Programme (Call: H2020-SC1-2016-RTD, H2020-EU.3.1.6. - Health care provision and integrated care) under Grant Agreement No. 733112.



DIN e. V.

Ulrike Schröder

Am DIN-Platz
Burggrafenstraße 6
10787 Berlin

Send message to contact