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FDA advances Precision Medicine Initiative by issuing draft guidance’s on next generation sequencing-based tests

In support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration issued two draft guidance’s that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup. The powerful new technology, known as next generation sequencing (NGS), can scan a person’s DNA to detect genomic variations that may determine whether a person has or is at risk of disease or may help to inform treatment decisions.