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

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

FDA recognizes NHGRI's ClinGen, dataset that ties genetic variants to disease

For the first time, the Food and Drug Administration has formally recognized a public dataset of genetic variants and their relationship to disease to help accelerate the development of reliable genetic tests. Genetic test makers, including those using next-gen sequencing, can use genetic variant information in the Clinical Genome Resource (ClinGen) to support clinical validity in premarket submissions to FDA. ClinGen is administered by the National Human Genome Research Institute, part of the National Institutes of Health, and is available via ClinVar.