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SPIDIA - Standardisation and improvement of pre-analytical procedures for in vitro diagnostics

Abstract
In vitro diagnostics have allowed a great deal of progress in medicine but are limited by two factors: *the lack of guidelines in collection, handling, stabilisation and storage of biosamples which limits the reproducibility of subsequent diagnoses, and *its scale is restraines to the cellular level. To address this first point, this IP, SPIDIA, built of clinicians, academics, tool developers and assay developers, aims to develop quality guidelines for molecular in vitro diagnostics and to standardize the pre-analytical workflow in related procedures. Regarding the second point, SPIDIA aims to develop modern pre-analytical tools for diagnostic improving the stabilisation, handling and study of free biomolecules within blood, plasma, serum, tissues and tumours. Recent discoveries have revealed that RNA, DNA or proteins, released from pathological sites, like tumour cells or Alzheimer's disease brain lesions, into the blood or as a secondary blood based response to the disease can serve as biomarkers for early and reliable molecular diagnosis of such debilitating diseases. Further discoveries have shown that the cellular profiles of these molecules and structures in clinical samples can change during transport and storage thus making clinical assay results and pharmaceutical research unreliable or even impossible. It will therefore be a decisive prerequisite for future and current diagnostic assays to develop standards and new technologies, tools and devices that eliminate the human error in the pre-analytical steps of in vitro diagnostics. At this crucial moment in the development of molecular diagnostics, SPIDIA proposes an IP that reunites 7 private research companies (including 4 SMEs) and 8 public research organisms, including universities, hospitals and biobanks and an official European Standards Organisation. This strong consortium is balanced and empowered to maximise the impacts of in vitro diagnostics on human health.
Schlagworte
Allgemeine Pathologie
Histologie
Molekulare Pathologie
Humangenetik
Genomik
Diagnostik in der Medizin
Alzheimer
biologische Proben
Biomarker
In-vitro Diagnostik
prä-analythisch
Projektleitung:
Zatloukal Kurt
Laufzeit:
17.12.2008-16.12.2012
Programm:
EU (FP-7)
Subprogramm
HEALTH-2007-1.2-5 (Health deadline 18. September 2007)
EU-Projektinstrument
Collaborative Project (Large-Scale Integrating Project)
Art der Forschung
Grundlagenforschung
Mitarbeiter/innen
Zatloukal K., Projektleiter/in
Abuja P., Projektmitarbeiter/in
Viertler C., Projektmitarbeiter/in
Moser M., Projektmitarbeiter/in
Kurzmann N., Projektmitarbeiter/in
Beteiligte MUG-Organisationseinheiten
Institut für Pathologie
Projektpartner
ACIES, Frankreich.
Aros Applied Biotechnology A/S, Dänemark.
Biotechnology Institute / Institute of Molecular Genetics of the Czech Academy of Sciences, Tschechische Republik.
Consorzio Interuniversitario Risonanze Magnetiche de Metalloproteine Paramagnetiche, Italien.
Dako Denmark A/S, Dänemark.
DiaGenic ASA, Norwegen.
Erasmus Medical Center Rotterdam, Niederlande.
European Commitee for Standardization, Belgien.
ImmunID Technologies, Frankreich.
International Agency for Research on Cancer, Frankreich.
PreAnalytiX GmbH, Schweiz.
QIAGEN GmbH, Deutschland.
TATAA Biocenter AB, Schweden.
Technische Universität München, München, Deutschland.
Universita degli Studi di Firenze, Florenz, Italien.
University of Erlangen, Deutschland.
Gefördert durch
Europäische Kommission, Rue de la Loi, Brussels, Europäische Union
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