A Roadmap for Regulatory Science Research for Next Generation Sequencing Informatics

Published

April 20, 2016

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

Pub Type

Journals

Download Paper

DOI Link

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 October 10, 2025)