FDA Recognizes Genomic Database to Advance Precision Medicine

The FDA has formally recognized a public database containing genomic information, a significant step forward in driving the development of precision medicine and novel diagnostic technologies. The agency is recognizing the genetic variant information in the Clinical Genome Resource (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data, a database funded by NIH. This recognition will allow test developers, including those who use next generation sequencing, to rely on the information in the database to support the validity of their tests instead of having to generate the information on their own.