FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

FDA on Tuesday formally recognized a public database that includes information about genes, genetic variants, and their relationship to disease.

FDA on Tuesday formally recognized a public database that includes information about genes, genetic variants, and their relationship to disease. The agency is recognizing the genetic variant information in the Clinical Genome Resource (ClinGen) consortium's ClinGen Expert Curated Human Genetic Data as a source of valid scientific information that can be used to support clinical validity in premarket submissions. "The availability of genetic tests is opening up new opportunities to segment illnesses into more treatable subsets and enabling the development of targeted therapeutics aimed at these previously unknown categories of disease," said FDA Commissioner Scott Gottlieb, MD. "These new medicines increasingly show outsized benefits in small populations of patients with rare, hard-to-treat and sometimes fatal conditions. The ability to use diagnostics to identify these rare subsets is a key element in driving this transformation in medical care and drug development."