Few startups have a foundational story as personal as that of 23andMe. After Anne Wojcicki founded the genetic-testing company in 2006, one of the first people to have his genome sampled using its technology was her then-husband, Google co-founder Sergey Brin. Brin's genotype report showed he had a mutation in a gene called LRRK2 that put him at elevated risk of developing Parkinson's disease.

Since then, Brin has donated tens of millions of dollars to Parkinson's research and made major lifestyle changes in hopes of reducing his risk. Since 2013, however, Wojcicki has been unable to provide her customers with the kind of knowledge that changed her ex-husband's life.

In that year, the Food and Drug Administration ordered 23andMe to stop providing information on disease risk. In the view of the FDA, the startup was peddling an unregulated medical device and short-circuiting the role doctors were meant to play in interpreting complex genetic data.

In 2015, I interviewed Wojcicki for Inc.'s Most Innovative Women Entrepreneurs issue. She told me about the mad sprint that ensued after the FDA handed down its edict. In the days following, she talked to every expert she could corral--lawyers, regulators, pharmaceutical executives, scientists--to devise a strategy that would get her product back into the FDA's good graces.

It took two years, but in October 2015, the FDA granted permission for 23andMe to resume providing consumers with some limited disease-risk information--carrier-status reports for a number of simple heritable conditions--along with curiosities like where their ancestors lived and whether they had the gene for a widow's peak.

Two years later, the company's comeback is nearly complete. On Thursday, the FDA announced that 23andMe will become the first direct-to-consumer test approved to provide genetic health risk information for some conditions. Those conditions include late-onset Alzheimer's, celiac disease, and Parkinson's--the one that started it all in the first place.

The agency says it approved the new risk reports after working with the company to establish new "special controls" to assure "the tests' accuracy, reliability, and clinical relevance." Also critical was a user study in which participants were able to understand more than 90 percent of the information presented to them in reports.

"We expect our first four reports on the genetic risk for Alzheimer's, Parkinson's, AATD, and Hereditary Thrombophilia to be available by the end of April," says a 23andMe spokeswoman. "We will add additional reports over time. There are no pricing changes for our products: Health + Ancestry is $199 and Ancestry Only is $99." Other conditions beyond the 10 recently approved will likely soon be added as well, with the FDA saying it will exempt future tests from premarket review.

Published on: Apr 6, 2017