1. National Human Genome Research Institute. Regulation of Genetic Tests. 2016. https://www.genome.gov/10002335/regulation-of-genetic-tests/. Accessed 8 June 2017.
2. US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases: Draft Guidance for Stakeholders and Food and Drug Administration Staff. Center for Biologics Evaluation and Research: Rockville, MD:, 2016.
3. US Department of Health and Human Service, Food and Drug Administration, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics: Draft Guidance for Stakeholders and Food and Drug Administration Staff. Center for Biologics Evaluation and Research: Rockville, MD, 2016.
4. Phillips KA, Deverka PA, Sox HC et al. Making genomic medicine evidence-based and patient-centered: a structured review and landscape analysis of comparative effectiveness research. Genet Med; e-pub ahead of print 13 April 2017.