Seeking 510(k) Clearance for Genomic Testing Service, 23andMe Maintains Direct-to-Consumer Ethos | GenomeWeb

Originally published July 31.

23andMe this week submitted the first of several 510(k) applications it plans to file in order to gain clearance from the US Food and Drug Administration for its Personal Genome Service. However, despite acquiescing to regulatory oversight, the firm hopes to keep marketing its genomic testing service directly to consumers.

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