ClinGen Database Validated by FDA

Prof. Heidi Rehm of Harvard Medical, lecturing
Thursday, December 6, 2018

ClinGen, a public genomic variant database, has been formally recognized by U.S. Food and Drug Administration (FDA) as a source of "valid scientific evidence that can be used to support clinical validity." This step is significant because it certifies that ClinGen provides accurate, accessible data to researchers who are developing genetic tests to help increase understanding of the causes of disease by researchers and health care providers, with the ultimate outcome of improving patient care. According to the FDA, "ClinGen brings together more than 700 clinical and research experts to develop standard processes for reviewing data and genetic variants and their connections to health and disease. The experts who are part of the consortium determine how each variant is associated with a specific hereditary disease or condition and make that information available for unrestricted use in the community." The Principal Investigator for the ClinGen project is Heidi Rehm; she outlined the need for undertaking this work and the challenges to correctly interpreting genetic variants in a Consortium-sponsored lecture you can view here