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- Title
Regulation of Next Generation Sequencing.
- Authors
Javitt, Gail H.; Carner, Katherine Strong
- Abstract
Next generation sequencing raises new questions within the context of an existing and still evolving regulatory landscape for device manufacturers and clinical laboratories. FDA cleared the first NGS sequencing platform in November 2013, but it is unclear what lies ahead for this technology. NGS will require new types of training and expertise to interpret the vast quantities of genetic data so as to provide meaningful clinical information to physicians and patients. This paper will describe the current regulatory landscape for NGS technologies, identify the regulatory challenges they present, and consider whether new regulatory paradigms are needed to accommodate NGS technologies and services.
- Subjects
UNITED States; GENOMICS; GOVERNMENT regulation &; economics; INTERPRETATION &; construction of American law; INDIVIDUALIZED medicine; MEDICAL technology; GENETIC databases; LAW; ECONOMICS; GENETIC testing; BIOTECHNOLOGY; DNA; HUMAN genome; MEDICAL genetics; PATHOLOGICAL laboratories; GOVERNMENT regulation; SEQUENCE analysis
- Publication
Journal of Law, Medicine & Ethics, 2014, Vol 42, p9
- ISSN
1073-1105
- Publication type
Article
- DOI
10.1111/jlme.12159