How Did 23andMe Stumble in Its Early Days?

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When the direct-to-consumer genetic testing powerhouse 23andMe was a mere infant, its leaders made a decision that would plunge the company into hot water with the FDA. In 2013, regulators banned 23andMe’s $99 at-home assessment for disease risk, citing the potential for incorrect results and their undesirable consequences. Now, at South by Southwest, one of the company’s cofounders said 23andMe was indeed in over its head.

Linda Avey, who left the $1.5 billion start-up in 2009, told a crowd that 23andMe didn’t enough have data to accurately inform people of their genetic risks for certain diseases.

“What we were trying to do was just too far of a reach,” she said. “It was too preliminary, and we really didn’t have enough data at that point. So, we had this really great ambition of educating people about genetics, but I just don’t think we had enough information to really draw the conclusions we did.”

If she were to go back in time, Avey would pull back on that aspect of the company, she said.

Of course, under orders from the FDA, 23andMe ultimately did halt distribution of its tests for disease susceptibility. It shifted its focus toward ancestry tests—a driver that Avey said was key from the outset and remains so today—and worked alongside the government to retool the risk assessments.

Last spring, the FDA approved a genetic risk test submitted by 23andMe and later announced plans to streamline its review process for similar analyses. And less than a week ago, the agency endorsed another direct-to-consumer test from the business, this one centered on mutations in BRCA breast cancer genes.

In its press release, the FDA noted that negative results couldn’t rule out the possibility of breast cancer, since the saliva review targeted just 3 of more than 1000 genetic mutations, a point that Avey also touched on.

“That’s not the full solution, right? But it’s a first pass,” she said, responding to a question about widespread testing of the whole genome, a phenomenon she expected might one day take shape.

The cofounder went on to say that the genetic tests are not predictive—but they are preventive. Her mother, for instance, tested positive for a mutation that is often responsible for Alzheimer’s. At 85 years old, her mom has not developed the disease.

Even so, Avey touted genetic risk tests as a means to develop communities of potential patients and empower them to take charge of their fates. “Even thought it might be something that’s a negative, people start to own it,” she said.

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