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CDx, NGS and regulation: five perspectives from the Pistoia Alliance.
- Source :
-
Drug discovery today [Drug Discov Today] 2019 Nov; Vol. 24 (11), pp. 2120-2125. Date of Electronic Publication: 2019 Jul 12. - Publication Year :
- 2019
-
Abstract
- 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.<br /> (Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Subjects :
- Biopharmaceutics legislation & jurisprudence
Biopharmaceutics methods
Biopharmaceutics trends
Diagnostic Tests, Routine trends
European Union
Molecular Diagnostic Techniques methods
Molecular Diagnostic Techniques trends
Precision Medicine trends
Diagnostic Test Approval legislation & jurisprudence
Diagnostic Tests, Routine standards
Government Regulation
High-Throughput Nucleotide Sequencing standards
Precision Medicine methods
Subjects
Details
- Language :
- English
- ISSN :
- 1878-5832
- Volume :
- 24
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Drug discovery today
- Publication Type :
- Academic Journal
- Accession number :
- 31306783
- Full Text :
- https://doi.org/10.1016/j.drudis.2019.07.002