Skip to main content
U.S. flag

An official website of the United States government

Dot gov

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

Https

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.

The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?

Published

Author(s)

Mark S. Lowenthal, Christina M. Jones, Joan Adamo, Robert Bienvenu, Owen Fields, Soma Ghosh, Michael Liebman, Robert Schuck, Scott Steele

Abstract

Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.
Citation
Journal of Clinical and Translational Science

Keywords

Precision Medicine, Regulatory Science, Omics, US Food and Drug Administration, Clinical and Translational Science Award
Created December 6, 2018, Updated April 19, 2020