The U.S. Food and Drug Administration announced draft guidances for the oversight of next-generation genomic sequencing (NGS). These guidances help to streamline oversight of NGS tests, which aim at detecting medically important differences in an individual’s genomic makeup.
“Targeting the right treatments to the right patients at the right time is the goal of the President’s Precision Medicine Initiative,” FDA Commissioner Dr. Robert Califf said in a statement. “Soon, patients will have a much more complete picture of their health than in the past, informed by their genetic and genomic makeup. The FDA is preparing for this exciting approach at multiple levels.”