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SPIDIA for Personalized Medicine - Standardisation of generic Pre-analytical procedures for In-vitro DIAgnostics for Personalized Medicine

Descripción del proyecto

DEENESFRITPL

Establecer directrices para la medicina personalizada

Los diagnósticos «in vitro» dependen de un procesamiento adecuado de las muestras para garantizar la fiabilidad de los resultados, la toma de decisiones informadas, así como tratamientos adecuados y oportunos, además de la mejora de los resultados de los pacientes. Sin embargo, la insuficiencia de directrices para las etapas del flujo de trabajo preanalítico y la inadecuada garantía de calidad de la práctica diagnóstica obstaculizan el progreso en el campo de la medicina personalizada. Para superar esta limitación, el equipo del proyecto SPIDIA4P, financiado con fondos europeos, propone generar y aplicar un conjunto completo de normas y especificaciones para flujos de trabajo preanalíticos, aplicables a la medicina personalizada, el descubrimiento de biomarcadores y los biobancos. El consorcio SPIDIA4P está formado por diecinueve socios que desarrollarán sistemas de garantía de calidad para evaluar la calidad de las muestras y las prácticas de diagnóstico.

Objetivo

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.

Ámbito científico

Programa(s)

Tema(s)

Convocatoria de propuestas

H2020-SC1-2016-2017

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Convocatoria de subcontratación

H2020-SC1-2016-RTD

Régimen de financiación

CSA - Coordination and support action

Coordinador

QIAGEN GMBH
Aportación neta de la UEn
€ 381 983,96
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)
Enlaces
Coste total
€ 381 983,96

Participantes (18)

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Última actualización: 23 Agosto 2022

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Permalink: https://cordis.europa.eu/project/id/733112/es

European Union, 2024