Companies developing products that either use or require genomic data to diagnose and treat patients now have a reliable database they can turn to support making claims, US FDA says. The agency officially said Dec. 4 it is recognizing the reliability of the data in the Clinical Genome Resource (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data. Sponsors can now confidently use the data in ClinGen as evidence in their product applications.
This is the first time FDA has formally recognized a public database that contains information about genes, genetic variants and their relationship to diseases. The ClinGen database, however, has been...