Becker's Healthcare December 7, 2018
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...
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