CDx, NGS and regulation: five perspectives from the Pistoia Alliance.

Biopharmaceutics / legislation & jurisprudence Diagnostic Test Approval / legislation & jurisprudence Diagnostic Tests, Routine / standards European Union Government Regulation High-Throughput Nucleotide Sequencing / standards Molecular Diagnostic Techniques / methods Precision Medicine / methods

Journal

Drug discovery today
ISSN: 1878-5832
Titre abrégé: Drug Discov Today
Pays: England
ID NLM: 9604391

Informations de publication

Date de publication:
11 2019
Historique:
received: 10 01 2019
revised: 24 06 2019
accepted: 09 07 2019
pubmed: 16 7 2019
medline: 10 6 2020
entrez: 16 7 2019
Statut: ppublish

Résumé

Companion diagnostics (CDx) are essential to the practice of precision medicine. Next-generation sequencing is an increasingly important tool in the development of CDx. However, for CDx to be deployed, many different biopharma industry sectors need to collaborate. This paper outlines some of the challenges and opportunities perceived by the biopharmaceutical industry, the Europe Molecular Quality Network, a regulatory agency, a notified body and a CDx service provider.

Identifiants

DOI: 10.1016/j.drudis.2019.07.002 PMID: 31306783
pubmed: 31306783
pii: S1359-6446(18)30465-3
doi: 10.1016/j.drudis.2019.07.002
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

2120-2125

Informations de copyright

Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

Auteurs

John Wise (J)

Pistoia Alliance, Wakefield, MA, USA. Electronic address: john.wise@pistoiaalliance.org.

Mike Furness (M)

Pistoia Alliance, Wakefield, MA, USA.

Stewart McWilliams (S)

Almac Group.

Simon Patton (S)

European Molecular Genetics Quality Network EMQN.

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Classifications MeSH

questionsmedicales.fr › Professions de santé › Pharmacologie › Biopharmacie › CDx, NGS and regulation: five perspectives...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Sécurité des produits de consommation › Agrément de dispositif › Agrément de test diagnostique › CDx, NGS and regulation: five perspectives...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Tests diagnostiques courants › CDx, NGS and regulation: five perspectives...
questionsmedicales.fr › Sciences sociales › Internationalité › Coopération internationale › Union européenne › CDx, NGS and regulation: five perspectives...
questionsmedicales.fr › Organisations et économie des soins de santé › Contrôle social formel › Réglementation gouvernementale › CDx, NGS and regulation: five perspectives...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Analyse de séquence › Séquençage nucléotidique à haut débit › CDx, NGS and regulation: five perspectives...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Techniques de diagnostic moléculaire › CDx, NGS and regulation: five perspectives...
questionsmedicales.fr › Professions de santé › Médecine › Médecine clinique › Médecine de précision › CDx, NGS and regulation: five perspectives...