Personal Genetics Company Seeks Regulatory Approval

08-03-2012 • http://www.technologyreview.com, Susan Young

Personal genetics company 23andMe announced it has applied for U.S. Food and Drug Administration approval for seven of its genetic tests. The company hopes that FDA approval will increase consumer confidence and interest in its tests, and ultimately feed into its goal of crowdsourcing human genetic information for medical research.

But it could be a risky move—if regulatory approval includes a requirement for a medical provider's involvement, that could interfere with the company's direct-to-consumer model, at least for some of its tests.

"That's the part where we are going to have to see how it plays out," says Linda Avey, a cofounder of 23andMe who has since left the company. The direct-to-consumer model was a founding principle of 23andMe, which emphasizes individual participation in health and medicine, says Avey.

23andMe, in which Google has invested $6.5 million, offers a genome analysis test directly to consumers, who can use the product to explore their genetic risk for everything from curly hair to Alzheimer's disease. Although the company isn't disclosing which particular tests it is seeking regulatory approval for, Ashley Gould, vice president for corporate development and chief legal officer, says the tests are medically relevant and examine genetic variants with disease connections that are well supported by scientific research. The company is already working on a second submission, and plans to eventually seek approval for some 100 of its 240 tests.