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FDA Recognizes ClinGen Database for Development of Clinical Tests

NEW YORK (GenomeWeb) – The US Food and Drug Administration said today that it is recognizing the Clinical Genome Resource consortium's ClinGen database as the first FDA-designated public genetic variants repository.

The approval is the first of its kind issued through agency's Human Variant Database Program, which is intended to help reduce regulatory burdens on companies developing next generation sequencing-based genetic tests and unfetter the advancement of precision medicine. The agency published its final guidance on the the subject earlier this year.

The newly announced recognition of ClinGen means that genetic test developers can access data from the repository, which is maintained via the National Institutes of Health-funded ClinVar archive, and can use it to support claims for their diagnostic tests without the need for additional FDA review to confirm the suitability of the database.

In a statement highlighting the FDA's announcement, ClinGen principal investigator and Baylor College of Medicine geneticist Sharon Plon said that the agency's recognition "highlights for the genetics community our goal of developing authoritative sources of clinical genetics that is publicly available to them," adding, "ClinGen is filling a critical need in the substantial challenge of gathering data and connecting it with the community for use in supporting genomic medicine and research."

Investigators published reports on a variety of insights that have emerged from the program in a special issue of the journal Human Mutation this October.

The green-light of ClinGen sanctions the database as providing classifications and supporting information specifically for germline variants for hereditary disease "where there is a high likelihood that the disease or condition will materialize given a deleterious variant," the FDA said in its approval.

The agency hasn't yet approved any databases for the classification of somatic variants but noted in April that recommendations related to somatic variant databases also fall within the scope of its public database guidance, suggesting that it may also approve specific somatic variant repositories at some point in the future.

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