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SPIDIA4P

SPIDIA for Personalized Medicine – Standardisation of generic Pre-analytical proced- ures for Invitro DIAgnostics for Personalized Medicine

Topic:  SC1-HCO-02-2016

Type of Action: CSA

Duration: 48 months

Start date: 1 January 2017

Grant agreement: 733112

Web: (not yet available)

Total request Grant by Consortium: €1,999,972.50

Total request Grant by BBMRI-ERIC: €100,673.75 (Headquarters Quality Service)

Linked Third Parties/BBMRI-ERIC Framework Agreement: none

Benefit/tasks for BBMRI-ERIC: standards to biobanks and reference centres, education and training programmes, industry-academia stakeholder workshop

 

Abstract

Molecular in vitro diagnostics and biomedical research have allowed great pro- gress in personalised medicine but further progress is limited by insufficient guidelines for pre-analytical workflow steps (sample collection, preservation, etc.) as well as by in- sufficient quality assurance of diagnostic practice. This allows using compromised pa- tients’ samples with post collection changes in cellular and extra-cellular biomolecules’ profiles thus often making diagnostic test results unreliable or even impossible. Thus, SPIDA4P aims to generate and implement a comprehensive portfolio of 22 pan-European pre-analytical CEN/TS and ISO/IS, addressing the important pre-analytical workflows ap- plied to personalized medicine. These will be applicable to biomarker discovery, devel- opment and validation as well as to biobanks. Corresponding External Quality Assurance Schemes will be developed and implemented (survey the resulting quality of samples and diagnostic practice). Additionally, SPIDIA4P will ensure stakeholder involvement as well as training, education, and counselling. We will closely coordinate with large European public research consortia to obtain access to research and validation studies data serving as evid- ence for the new standards developments and achieved improvements of diagnosis, patient stratification and prognosis of disease outcome.

List of Participants

Qiagen Gmbh (QIA), Lgc Limited (LGC), Technische Universität München (TUM), DIN Deutsches Institut Fuer Normung E.V. (On Behalf Of CEN) (DIN), Preanalytix Gmbh (PAX), Inivata Ltd (INIVATA), Cambridge Protein Arrays Ltd (CPA), Tataa Biocenter Ab (TATAA), Universita Degli Studi di Firenze (UNIFI), Consorzio Inter- universitario Risonanze Magnetiche di Metallo Proteine (CIRMMP), Universita Degli Studi di Trieste (UNITIS), Universita Degli Studi di Torino (UNITO), Biobanks And Biomolecu- lar Resources Research Infrastructure Consortium (BBMRI-ERIC), Luxembourg Institute Of Health (IBBL), Medizinische Universitaet Graz (MUG), Institut National De La Sante Et De La Recherche Medicale (INSERM), Erasmus Universitair Medisch Centrum Rotterdam (EMC), Fundacio Centre De Regulacio Genomica (CNAG-CRG), Fondazione Irccs Istituto Nazionale Dei Tumori (INT).

 

SPIDIA4P is funded by the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733112.

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