Project description
Setting guidelines for personalised medicine
In vitro diagnostics rely on proper sample processing to ensure result reliability, informed decision-making as well as appropriate and timely interventions, and improved patient outcomes. However, insufficient guidelines for pre-analytical workflow steps and inadequate quality assurance of diagnostic practice hinder progress in the field of personalised medicine. To overcome this limitation, the EU-funded SPIDIA4P project proposes to generate and implement a comprehensive set of standards and specifications for pre-analytical workflows, applicable to personalised medicine, biomarker discovery and biobanks. The SPIDIA4P consortium comprises 19 partners who will develop quality assurance schemes to assess sample quality and diagnostic practices.
Objective
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 pan-European 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. The 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 and achieved improvements of diagnosis, patient stratification and prognosis of disease outcome.
At this crucial moment in the development of personalised medicine, SPIDIA4P proposes a coordination and support action that reunites 19 highly experienced partners in international standardisation for in vitro diagnostics, coming from private industry including SMEs, public institutions and from one official European Standards Organisation. This strong consortium is balanced and empowered to maximise the impacts of in vitro diagnostics on personalised medicine.
Fields of science
Programme(s)
Funding Scheme
CSA - Coordination and support actionCoordinator
40724 Hilden
Germany
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Participants (18)
TW11 0LY Teddington
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80333 Muenchen
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10787 Berlin
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8634 HOMBRECHTIKON
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CB2 0RE CAMBRIDGE
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CB22 3AT CAMBRIDGE
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
412 51 GOTEBORG
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
50121 Florence
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50121 FIRENZE
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34127 Trieste
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10124 Torino
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8010 Graz
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1445 Strassen
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8010 Graz
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75654 Paris
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3015 GD Rotterdam
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08003 Barcelona
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20133 Milan
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