Genetics Tests Ordered by Doctors Race to Market, While ‘Direct-to-Consumer’ Tests Hinge on FDA Approval

March 16, 2018

(STAT News) – The Food and Drug Administration is keeping tight watch on “direct-to-consumer” genetic tests but has been taking a hands-off approach with similar tests that have a crucial distinction: a physician’s sign-off. A physician order appears to be a key regulatory difference between companies like 23andMe, whose tests FDA has said must seek official approval, and companies like Color Genomics, Helix, and Veritas, who are offering some similar tests but don’t need the agency’s permission.

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