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

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

Objective

In vitro diagnostics have allowed a great deal of progress in medicine but are limited by two factors: (a) the lack of guidelines in collection, handling, stabilisation and storage of biosamples which limits the reproducibility of subsequent diagnoses, and (b) its scale is restrained to the cellular level. To address this first point, this IP, SPIDIA, built of clinicians, academics, tool 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 diagnostics 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 (AD) 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), 1 private research institute, 6 public research organisms, including universities, hospitals and biobanks, one management SME and an official European Standards Organisation. This strong consortium is balanced and empowered to maximise the impacts of in vitro diagnostics on human health.
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Coordinator

QIAGEN GMBH

Address

Qiagen Strasse 1
40724 Hilden

Germany

Activity type

Other

EU Contribution

€ 2 048 002

Administrative Contact

Ann Vinckier (Dr.)

Participants (16)

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MEDIZINISCHE UNIVERSITAT GRAZ

Austria

EU Contribution

€ 1 107 412

CONSORZIO INTERUNIVERSITARIO RISONANZE MAGNETICHE DI METALLO PROTEINE

Italy

EU Contribution

€ 340 020

TATAA BIOCENTER AB

Sweden

EU Contribution

€ 539 680

PREANALYTIX GMBH

Switzerland

DIAGENIC ASA

Norway

EU Contribution

€ 579 374

AROS APPLIED BIOTECHNOLOGY AS

Denmark

EU Contribution

€ 604 410

DAKO DENMARK A/S

Denmark

EU Contribution

€ 640 200

ACIES SAS

France

EU Contribution

€ 16 721

BIOTECHNOLOGICKY USTAV AV CR VVI

Czechia

EU Contribution

€ 275 000

COMITE EUROPEEN DE NORMALISATION

Belgium

EU Contribution

€ 100 000

IMMUNID TECHNOLOGIES

France

EU Contribution

€ 419 952

UNIVERSITA DEGLI STUDI DI FIRENZE

Italy

EU Contribution

€ 1 142 056

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM

Netherlands

EU Contribution

€ 549 183

TECHNISCHE UNIVERSITAET MUENCHEN

Germany

EU Contribution

€ 286 534

FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI

Italy

EU Contribution

€ 95 000

NOVAMEN SAS

France

EU Contribution

€ 238 252

Project information

Grant agreement ID: 222916

Status

Closed project

  • Start date

    1 October 2008

  • End date

    31 March 2013

Funded under:

FP7-HEALTH

  • Overall budget:

    € 13 823 601

  • EU contribution

    € 8 981 796

Coordinated by:

QIAGEN GMBH

Germany

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