Will 23AndMe’s Genetic Tests Ever Be Legal?

 
 
 

Last Monday, the Food and Drug Administration announced that 23andMe’s $99 Personal Genome Service is in violation of the Federal Food, Drug and Cosmetic Act, according to CNBC, effectively shutting down the genetic profiling company.

23andMe — founded by former Wall Street analyst and Sergey Brin ex-wife Anne Wojcicki — has seen over 220,000 signups this year alone, and has raised over $126 million in venture capital funding.

In a publicly-released letter to Ms. Wojcicki, FDA director Alberto Gutierrez expressed concern that the genetic tests may encourage patients to “self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.” Simply put, Angeline Jolie’s preventative double mastectomy earlier this year may not be the example the FDA wants people to follow. But are government regulators just behind the times?

Eric Rosenbaum of CNBC thinks so, noting the irony that American consumers can test their luck in lotteries and casinos, but can’t regulate their own health risks at the genetic ‘poker table.’

The ban was based on hundreds of interactions with 23andMe executives, according to the FDA letter, although Gutierrez also notes that the FDA will continue working with 23andMe to bring the company’s standards into compliance.