ClinGen Receives Recognition from FDA

The Food and Drug Administration (FDA) has formerly recognized the ClinGen database that contains information about genes, genetic variants, and their relationship to disease. This is the first time the FDA has done so. This FDA recognition will facilitate genetic test developers.

The FDA’s purpose is to drive the efficient development of novel diagnostic technologies that scan a person’s DNA to diagnose genetic diseases and guide medical treatments.

The FDA’s recognition of the ClinGen consortium’s ClinGen Expert Curated Human Genetic Data as a source of valid scientific evidence that can support clinical validity is significant. It means that developers of genetic tests will have assurance of the reliability of the freely available data that they can use in support of their applications for marketing authorizations with the agency, rather than generating the same data on their own.

The FDA provided an example of how this can be used. The sponsor of a test that detects variants involved in hereditary cardiomyopathy could point to the cardiomyopathy genetic variant information in ClinGen as part of a submission to support clinical validity of their test.

Genetic tests work by looking at a person’s DNA to detect genomic variations that may determine whether a person has or is at risk of developing a genetic disease. And, in certain cases, may help to inform treatment decisions. Unlike traditional diagnostics that typically detect chemical changes associated with a single disease or condition, DNA-based assays can look at hundreds to millions of DNA changes in a single test to help determine the cause of a person’s disease or condition.

The result of the FDA’s recognition of the ClinGen database is good news for genealogists. There could potentially be new genetic tests created that can determine the risk of developing specific diseases (including ones that run in your family). Ideally, the test will be connected to innovative treatments or cures, recommended by doctors.

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