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Integrated and standardized NGS workflows for Personalised therapy

Descrizione del progetto

Nuovi flussi di lavoro per la terapia personalizzata nei tumori

Per i fornitori di oncologia clinica, conoscere il potenziale e i limiti del sequenziamento del DNA può essere fondamentale per fornire assistenza genomica ai pazienti. Grazie ai progressi tecnologici è ora possibile applicare un sequenziamento di nuova generazione (NGS, Next Generation Sequencing) ad alte prestazioni nella pratica clinica standard. I protocolli accumulati per l’analisi e l’interpretazione dei dati NGS e delle basi di conoscenze consentiranno ai medici di fornire cure più mirate per i loro pazienti. Il progetto Instand-NGS4P, finanziato dall’UE, svilupperà flussi di lavoro NGS innovativi da una fase preanalitica a campione incentrata sulle patologie dei pazienti per la diagnostica di routine di tumori comuni e rari sia infantili che dell’adulto. Un NGS completamente integrato e standardizzato sarà creato in collaborazione con i principali centri medici con esperienza nelle piattaforme NGS nella ricerca, gruppi europei di difesa dei pazienti e organismi di normalizzazione.

Obiettivo

Instand-NGS4P is a 65-month PCP project federating 7 leading medical centers (two are coordinating ERNs) as buyers’ group with major experience in using different NGS platforms in research and routine diagnostics. The consortium is further strengthened by European patient advocacy groups, a standardization organization and partners participating in the European infrastructures BBMRI-ERIC, ELIXIR as well as several NGS-related EU programs to cover all technical aspects and transversal needs & requirements. Driven by patient and clinical needs, innovative NGS workflows from sample-pre-analytics to medical decision making will be developed. The modular design of the workflow will particularly enable SEMs to contribute, and provides flexibility to adopt emerging user needs and technologies. Specifications will address regulatory requirements for IVDs and refer to international standards and requests development of reference materials and implementation of EQA schemes covering the whole workflow. R&D suppliers will be selected based on a public tender all along this PCP process in 3 phases according to the best-value for money solution. The 3 phases foresee the leverage of 4 technical modules (pre-analytics, sequencing, bioinformatics, e-reporting/e-medication) and their standardized interfaces – from design (Phase 1) to prototypes (Phase 2), and full integration in Phase 3. At the end, this PCP will provide 2 fully integrated, standardized NGS workflows for routine diagnostics of common and rare cancers from adults to children. In order to enable broad implementation in healthcare systems throughout Europe and beyond and to increase benefit to patients a series of support activities are planned including communication and dissemination activities targeting a broad stakeholder community, development of training and education material for healthcare professionals and patients, health economic assessment and engagement with healthcare payers and policy makers.

Invito a presentare proposte

H2020-SC1-BHC-2018-2020

Vedi altri progetti per questo bando

Bando secondario

H2020-SC1-2019-Single-Stage-RTD

Meccanismo di finanziamento

PCP - Pre-Commercial Procurement

Coordinatore

MEDIZINISCHE UNIVERSITAT GRAZ
Contribution nette de l'UE
€ 8 140 561,32
Indirizzo
NEUE STIFTINGTALSTRASSE 6
8010 Graz
Austria

Mostra sulla mappa

Regione
Südösterreich Steiermark Graz
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
€ 9 045 068,13

Partecipanti (23)