23andMe's rocky relationship with the FDA

It is Thursday, January 24, 2019. In case you forgot.

23andMe nabs another win with fresh FDA approval 

On Tuesday, DNA testing company 23andMe announced that the company received clearance from the FDA (shoutout to the fine folks at the FDA working without pay) to report on genetic variants that influence a hereditary colorectal cancer syndrome as part of the company’s Health + Ancestry Service.

The announcement, which may not appear to be a big deal at first glance, marks another milestone in 23andMe’s remarkable turnaround since they were essentially shut down by the FDA in 2013.

Company ancestry

Founded in 2006 by Anne Wojcicki, Linda Avery, and Paul Cusenza (Wojcicki is the current CEO, Avery and Cusenza have since departed the company), 23andMe’s product was originally designed to provide users with genetic health information including disease risk and predisposition to certain conditions.

At first, things were going swimmingly for 23andMe. The company raised more than $100 million in its first six years of operation, including investments from Genentech and Google (fun fact: Wojcicki was married to Google co-founder Sergey Brin from 2007-2015).

However, behind the scenes there was an increasing tension between the company and the FDA, which worried that the test results were too easy to misinterpret.

Trouble helix

It came to a head in November 2013 when the FDA issued a warning to 23andMe to stop selling its Personal Genome Service until it received the organization's approval.

For nearly four years, the company was forced to market a product limited to providing ancestry results (which produced shocking revelations for some) while the 23andMe team worked to secure the FDA’s approval for its genetic health testing.

Positive results

Finally in April 2017, 23andMe was granted FDA approval to report genetic risk results for 10 conditions. More good news followed in March 2018 when the company secured the first FDA approval for a direct-to-consumer test for cancer risk.

Tuesday’s announcement marks 23andMe’s third big win in the last two years.
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Zac Cherin
Brendan Uyeshiro
Brendan Uyeshiro