Outside Publication

FDA Streamlines Reviews Of Next Generation Sequencing Tests

August 02, 2016

The U.S. Food and Drug Administration issued two draft guidance documents on July 8 for next generation sequencing (NGS)-based tests as part of the White House’s Precision Medicine Initiative, which was launched to encourage the development of health care treatment and prevention strategies that are tailored to people’s unique characteristics, including genome sequence, microbiome composition, health history, lifestyle and diet. A critical component of the initiative is to promote development of tests designed to analyze a person’s genetic sequence, to aid in the diagnosis of individuals with certain suspected diseases or conditions. These efforts have become even more pressing with the president’s announcement of the National Cancer Moonshot initiative.

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