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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.
- Keywords
- general pathology
- histology
- Molecular pathology
- human genetics
- Genomics
- medical diagnostics
- Alzheimer
- biologische Proben
- Biomarker
- In-vitro Diagnostik
- prä-analythisch
- Local Subprojectlead:
- Zatloukal Kurt
- Duration:
- 01.10.2008-31.03.2013
- Programme:
- EU (FP-7)
- Subprogramme
- HEALTH-2007-1.2-5
- EU-Project Instruments
- Collaborative Project (Large-Scale Integrating Project)
- Type of Research
- basic research
- Staff
- Zatloukal, Kurt, Project Leader
- Abuja, Peter Michael, Co-worker
- Viertler, Christian, Co-worker
- Moser, Monika, Co-worker
- Kurzmann, Nicole, Co-worker
- MUG Research Units
- Diagnostic and Research Institute of Pathology
- Project partners
- ACIES, France
- Aros Applied Biotechnology A/S, Denmark
- Biotechnology Institute / Institute of Molecular Genetics of the Czech Academy of Sciences, Czech Republic
- Consorzio Interuniversitario Risonanze Magnetiche de Metalloproteine Paramagnetiche, Italy
- Dako Denmark A/S, Denmark
- DiaGenic ASA, Norway
- Erasmus Medical Center Rotterdam, Netherlands
- European Commitee for Standardization, Belgium
- ImmunID Technologies, France
- International Agency for Research on Cancer, France
- PreAnalytiX GmbH, Switzerland
- QIAGEN GmbH, Germany
- TATAA Biocenter AB, Sweden
- Technische Universität München, Germany
- Universita degli Studi di Firenze, Italy
- University of Erlangen, Germany
- Project results published
- > Biobanken: Keine Translation ohne Standardisierung... Itranskript. 2014. 20. Jahrgang 2014: 30-30. (ISSN: )
- > European and other international governance initia... 4th Symposium of the Swiss Clinical Trial Organisation (SCTO) and the University Hospitals Geneva (HUG); JUN 20, 2013; Geneva, Swiss. 2013.
- > BBMRI expert centres & public/private partnership... Brocher Workshop ; JUN 12-14, 2013; Genf. 2013.
- > Tissue Banking - European perspectives... 97. Jahrestagung der Deutschen Gesellschaft für Pathologie; Mai 23-26, 2013; Heidelberg, Deutschland. 2013.
- > Biobanking and the future of medicine & standardiz... China Biobank development Strategy Workshop; Nov, 08-11, 2102; Shanghai, China. 2012.
- > Sustainability:ESFRI integration... EVA-BBMRI Meeting; Dezember, 6, 2012; Berlin, GERMANY. 2012.
- > How to Improcve Interoperability of Biobankds: Eur... European Lab Automation; MAY 30-31, 2012; Hamburg, GERMANY. 2012.
- > Key Infrastructre for personalized medicine ... ÖAW Symposium Personalisierte Medizin; Januar, 13-14, 2012; Wien. 2012.
- > Gewebebanken: Chancen und Risiken für die Genomfor... EURAT Sympsoium; 15.03.2012; Heidelberg. 2012.
- > Biobanks a key resource for Biomarker Development... Biomarker Symposium; Oktober, 3, 2012; Wien. 2012.
- > The role of biobanking in personalized medicine... Translational Reserch in Oncology - a new approach to personalized medicine; Mai, 8-9, 2012; Forli, ITALY. 2012.
- > The European Biobanking and Biomolecular Resources... International Symposium - National Biobank of Korea; April 25-27, 2012; Korea. 2012.
- > Addressing global health challenges through resear... European Health Forum - Gastein; Oktober, 4-5, 2012; Gastein. 2012.