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US FDA Hopes ClinGen Database Will Spur Next-Gen Sequencing Products

The agency says it has evaluated ClinGen and will accept evidence based on the US National Institutes of Health-funded database for product applications. It hopes the use of the database will spur development of targeted treatments and diagnostics such as next generation sequencing tests.

DNA

Companies developing products that either use or require genomic data to diagnose and treat patients now have a reliable database they can turn to support making claims, US FDA says. The agency officially said Dec. 4 it is recognizing the reliability of the data in the Clinical Genome Resource (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data. Sponsors can now confidently use the data in ClinGen as evidence in their product applications.

This is the first time FDA has formally recognized a public database that contains information about genes, genetic variants and...

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