23andMe found itself in trouble with the US Food and Drug Administration in 2013.
The FDA instructed 23andMe to stop marketing its genetic health screening service in the United States until it completed the agency’s regulatory review process. The company could continue selling its ancestry service.
23andMe complied with the FDA’s request, meaning it only provided users with Ancestry reports and raw data.
Wojcicki discussed the FDA’s regulation during an appearance at the SXSW festival in 2014.
“It has slowed up the number of people signing up,” Wojcicki said, according to The Guardian.
She added: “We are pioneers. We’ve had a lot of ups and downs but we have lots of tenacity to push on through. It will take time, money, and effort to figure out the path forward.”
The company met the FDA’s standard in 2015.
“The new 23andMe experience reflected almost two years of work with regulators, our scientists, medical experts, and product designers,” the company said. “The result is the first direct-to-consumer test available directly to individuals in the United States that includes reports that meet FDA requirements for being scientifically and clinically valid.”