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Dangerous diagnostics? Regulatory reform in the genomic era

Accepted version
Peer-reviewed

Type

Article

Change log

Authors

Holloway, Kelly 
Miller, Fiona A 
Gutierrez, Alberto 

Abstract

Molecular diagnostics are expanding rapidly yet many have not been externally evaluated. Kelly Holloway and colleagues identify failings in the regulatory system and report on recent efforts at reform

Description

Keywords

Advisory Committees, Genomics, Government Regulation, Harm Reduction, Health Care Reform, Humans, Marketing of Health Services, Precision Medicine, Reagent Kits, Diagnostic

Journal Title

BMJ: British Medical Journal

Conference Name

Journal ISSN

0959-535X
1756-1833

Volume Title

364

Publisher

BMJ Publishing Group
Sponsorship
European Research Council (716689)