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A Roadmap for Regulatory Science Research for Next Generation Sequencing Informatics



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


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.
Science Translational Medicine


precision medicine, biology, DNA sequencing, standards


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], (Accessed May 30, 2024)


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Created April 20, 2016, Updated November 10, 2018