The FDA formally recognized Clinical Genome Resource consortium's ClinGen Expert Curated Human Genetic Data, a public genomic database, as a source of valid scientific evidence.
Evidence from the database, which is funded by the National Institutes of Health, can now be used to support clinical validity in premarket FDA submissions. Test developers can use information from the database rather than having to generate information for themselves. Additionally, test developers will not have to demonstrate the reliability of the database to the agency.
In April, the FDA issued a final guidance that showcased the benefits of public databases for the accelerated development of genetic tests. The agency recognized the ClinGen database using the process detailed in the final guidance, reviewing ClinGen's standard operating procedures and policies as well as policies for how the consortium qualifies and approves researchers and clinicians to assess gene variants.
"The FDA is committed to supporting the development of these novel technologies that provide critical, potentially life-saving information," said FDA Commissioner Scott Gottlieb, MD, in a statement. "With our policies, we’ve sought to create an efficient regulatory pathway that promotes the more rapid development of important tests that can transform medical care while assuring their accuracy and clinical relevance. Our continued efforts, including today's recognition, will advance this process and help patients gain access to more sophisticated tests that provide important genetic information, allowing for more targeted medical care."