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Medical Devices / Regulatory Affairs

FDA Recognizes First Human Genetic Variant Database

Dec. 6, 2018
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The FDA announced that it has recognized, for the first time, a publicly available genetic variants database that can be used to support clinical claims in diagnostic tests.

The agency acknowledged the Clinical Genome Research (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data as the first public database. Genetic test developers, including those who offer next generation sequencing tests, can access the database through ClinVar, an NIH-funded archive.

“The goal of ClinGen is to bring together clinical and research experts to develop standard processes for reviewing data about gene variants and their connections to health and disease,” the agency said.

The recognition means that “genetic test developers can use this data to support the clinical validity of their tests, without the need for additional FDA review to confirm the suitability of the database,” the FDA said.

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