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 peoples 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 persons genetic makeup, or the genetic profile of an individuals 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 Obamas Precision Medicine Initiative seeks to identify genetically-based drivers ofdisease in order to develop new, more effective treatments. FDAs 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 persons 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.

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, weve been issuing discussion papers, holding workshops and collaborating with our stakeholders.

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.

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Precision Medicine - Food and Drug Administration

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