FDA guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine
- PMID: 30302274
- PMCID: PMC6170456
- DOI: 10.1038/s41525-018-0067-2
FDA guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine
Conflict of interest statement
The Authors declare no competing interests.
References
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- U.S. Food and Drug Administration (FDA). Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended to Aim in the Diagnosis of Suspected Germline Diseases. Updated 13 April 2018. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance... (2018).
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- National Institutes of Health (NIH). National Human Genome Research Institute. The Cost of Sequencing a Human Genome. https://www.genome.gov/27565109/the-cost-of-sequencing-a-human-genome/. (2016).
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- National Center for Biotechnology Information (NCBI) Genetic Testing Registry (GTR) online database. https://www.ncbi.nlm.nih.gov/gtr/docs/about/. (2018).
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