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23andMe relaunching health tests with nod from FDA

| | October 22, 2015

This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

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The genetic testing company 23andMe has announced that it’s relaunching its direct-to-consumer health testing kits after shutting them down two years ago when the Food and Drug Administration charged the company with failing to provide evidence that their tests were “analytically or clinically validated.”

Like other California-based startups (such as Theranos), 23andMe had charged ahead with promises to disrupt health care. The 23andMe co-founder, Anne Wojcicki, said the company was poised to become the “world’s trusted source of personal genetic information” and “empowering” users with information about their genetic makeup.

But that revolutionary language didn’t pass muster with health regulators. Many of the genetic analyses 23andMe was giving to consumers hadn’t yet been validated or FDA-approved, so the the company’s health service had to slow down and reboot for a couple of years before coming back online.

 

Read full, original post: The FDA ordered 23andMe to stop offering users unapproved health tests. Now it’s back.

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