Science & Research

Precision Medicine Initiative

Update: Streamlining Regulatory Oversight for Next Generation Sequencing Tests

In support of the White House’s Precision Medicine Initiative, the FDA issued two draft guidances that offer a streamlined approach to the oversight of 'Next Generation Sequencing' tests that detect medically important differences in a person’s genomic makeup.

FDA's Role in the Precision Medicine Initiative

Most medical treatments are designed for the "average patient " as "one-size-fits-all-approach," that is successful for some patients but not for others. Precision medicine, sometimes known as "personalized medicine" is an innovative approach to disease prevention and treatment that takes into account differences in people’s genes, environments and lifestyles.

Advances in precision medicine have already led to powerful new discoveries and several new FDA-approved treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor. Patients with a variety of cancers routinely undergo molecular testing as part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

To advance these developments, President Obama’s Precision Medicine Initiative seeks to identify genetically-based drivers of disease in order to develop new, more effective treatments. FDA’s role is to ensure the accuracy of genetic tests, many of which are derived from next generation sequencing, a rapid and fairly inexpensive technology that collects data on a person’s entire genome. Researchers are combing through segments of this data to look for genetic variants, potentially meaningful differences that might eventually result in a treatment.

What FDA is Doing Now

However, the vast amount of information generated through next generation sequencing (NGS) poses novel regulatory issues for FDA. Recognizing these challenges, FDA is at work on a workable regulatory platform that will encourage innovation while ensuring accuracy. To get there, we’ve been issuing discussion papers, holding workshops and collaborating with our stakeholders.

FDA's Informatics Platform

In addition, FDA has created precisionFDA, a community research and development portal that allows for testing, piloting, and validating existing and new bioinformatics approaches to NGS processing.


Please contact us with any questions about FDA’s role in the Precision Medicine Initiative at

Page Last Updated: 10/03/2016
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