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

Objetivo

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.

Ámbito científico

Palabras clave

Programa(s)

Tema(s)

Convocatoria de propuestas

FP7-HEALTH-2007-B
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Régimen de financiación

CP-IP - Large-scale integrating project

Coordinador

QIAGEN GMBH
Aportación de la UE
€ 2 048 002,00
Dirección
QIAGEN STRASSE 1
40724 Hilden
Alemania

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Región
Nordrhein-Westfalen Düsseldorf Mettmann
Tipo de actividad
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contacto administrativo
Ann Vinckier (Dr.)
Enlaces
Coste total
Sin datos

Participantes (16)

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Última actualización: 25 Mayo 2017

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Permalink: https://cordis.europa.eu/project/id/222916/es

European Union, 2024