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.

Get the full story with
GenomeWeb Premium

Only $95 for the
first 90 days*

A trial upgrade to GenomeWeb Premium gives you full site access, interest-based email alerts, access to archives, and more. Never miss another important industry story.

Try GenomeWeb Premium now.

Already a GenomeWeb Premium member? Login Now.
Or, See if your institution qualifies for premium access.

*Before your trial expires, we’ll put together a custom quote with your long-term premium options.

Not ready for premium?

Browse our free articles
You can still register for access to our free content.

In Cell this week: proteomic consequences of genomic changes in ovarian cancer, Human SRMAtlas, and more.

At Nature, John Wilbanks and Eric Topol call for openness in health data. predicts that genomic and genetic testing will become common in toxic tort cases.

A Pew Research Center report finds that most Americans are wary of using technologies like gene editing to enhance human abilities.