FDA Recognizes ClinGen Database for Development of Clinical Tests

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 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.

Source: https://www.jdsupra.com/legalnews/diagnostic-imaging-services-must-follow-67406/