A huge comeback for the Alphabet-backed startup.

By Sy Mukherjee
April 6, 2017

The $1.1 billion Alphabet-backed Silicon Valley unicorn 23andMe just pulled off a milestone feat: On Thursday, the Food and Drug Administration (FDA) said the company could sell its genetic tests and accompanying health risk reports for ten different diseases directly to consumers. That means that, for the first time ever, Americans won’t have to get a prescription to receive plain-English medical reports about their chances of developing diseases like Alzheimer’s, Parkinson’s disease, celiac disease, and other disorders based on analyses of their genetic makeup.

“The FDA has embraced innovation and has empowered people by authorizing direct access to this information,” said 23andMe co-founder and CEO Anne Wojcicki in a statement. “It is a significant step forward for 23andMe and for the adoption of personal genetics.”

This moment has been a long time coming for the company, which is now the first and only one in the U.S. that can provide such health reports to consumers without a prescription. In late 2013, the FDA sent Wojcicki a warning letter stating that the firm’s Saliva Collection Kit and Personal Genome Service (PGS) was being marketed to consumers without proper regulatory clearance. The PGS platform promised genetic risk reports for more than 250 disease at the time—but, after the FDA smackdown, 23andMe was forced to stop marketing the service and pursue a piecemeal strategy of winning regulatory approval of individual tests. In February 2015, the FDA authorized its direct-to-consumer test for the rare disorder Bloom syndrome.

But Thursday’s approval is far more significant because it allows 23andMe to, not just provide DTC genetic testing for a range of diseases, but also send customers reports about their genetic risks “which may help [them] to make decisions about lifestyle choices or to inform discussions with a health care professional,” according to the FDA.

To get to this point, 23andMe had to conduct extensive studies proving the accuracy of its tests and assuring regulators that the reports can be easily understood by consumers so that they can make informed health care decisions.

Still, the FDA offered up a word of warning over the newly available tests.

“[I]t is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease,” said Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

This essay appears in today’s edition of the Fortune Brainstorm Health Daily. Get it delivered straight to your inbox.

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