Title |
Regulation of Next Generation Sequencing
|
---|---|
Published in |
The Journal of Law, Medicine & Ethics, January 2021
|
DOI | 10.1111/jlme.12159 |
Pubmed ID | |
Authors |
Gail H. Javitt, Katherine Strong Carner |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Canada | 1 | 33% |
Sweden | 1 | 33% |
Unknown | 1 | 33% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 3 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 1 | 6% |
Sweden | 1 | 6% |
Unknown | 15 | 88% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Other | 4 | 24% |
Student > Ph. D. Student | 4 | 24% |
Student > Master | 3 | 18% |
Researcher | 3 | 18% |
Student > Postgraduate | 2 | 12% |
Other | 0 | 0% |
Unknown | 1 | 6% |
Readers by discipline | Count | As % |
---|---|---|
Biochemistry, Genetics and Molecular Biology | 4 | 24% |
Agricultural and Biological Sciences | 4 | 24% |
Medicine and Dentistry | 3 | 18% |
Social Sciences | 2 | 12% |
Physics and Astronomy | 1 | 6% |
Other | 1 | 6% |
Unknown | 2 | 12% |