Skip to main content
U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

A Roadmap for Regulatory Science Research for Next Generation Sequencing Informatics

Published

Author(s)

Justin M. Zook, Marc L. Salit, Russ B. Altman, Arend Sidow, Rachel Goldfeder, Euan Ashley, Elizabeth Mansfield

Abstract

The Precision Medicine Initiative (PMI) is a national effort in the United States “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care”. One of goals of this effort is to bring about the routine use of the next generation of precision diagnostics to benefit individuals and the public health. Central to the introduction of safe and effective new precision diagnostic technologies is an adequate understanding of how they perform, both in terms of their likely benefits and their limitations. Through the PMI, FDA is seeking to address this by providing dynamic, flexible, and well-balanced regulation of precision diagnostics. . Because these complex technologies pose new challenges in understanding with respect to limits in terms of accuracy, precision and clinical validity, FDA is advancing a robust research agenda in regulatory science. New knowledge gained from this agenda will inform the next generation of regulation for precision medicine.
Citation
Science Translational Medicine
Volume
8
Issue
335

Keywords

precision medicine, biology, DNA sequencing, standards

Citation

Zook, J. , Salit, M. , Altman, R. , Sidow, A. , Goldfeder, R. , Ashley, E. and Mansfield, E. (2016), A Roadmap for Regulatory Science Research for Next Generation Sequencing Informatics, Science Translational Medicine, [online], https://doi.org/10.1126/scitranslmed.aaf7314 (Accessed May 30, 2024)

Issues

If you have any questions about this publication or are having problems accessing it, please contact reflib@nist.gov.

Created April 20, 2016, Updated November 10, 2018