Lawyer: FDA-Approved Database May Help Genetic Tests Reach Market

By David Roza
December 5, 2018 at 2:09 PM
A device and diagnostics lawyer says FDA’s formal recognition of a public database of information about genes, genetic variants and their relationship to disease could help new genetic tests reach market. FDA announced on Tuesday (Dec. 4) that it considered the Clinical Genome Resource (ClinGen) consortium’s ClinGen Expert Curated Human Genetic Data to be a source of valid scientific evidence that can be used to support clinical validity in premarket submissions. Funded by the National Institutes of Health, the information...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on the coming Democrat-controlled House of Representatives, drug pricing reforms, Medicaid policy, FDA news and much more.