Last Monday, the U.S. Food and Drug Administration posted a letter on its website demanding that genetic testing company 23andMe stop selling its personalized DNA test kits.
The FDA letter has sparked a debate over the role of regulation in the ever-expanding marketplace of personalized genome testing services, raising ethical and legal questions about how to regulate genetic information. Much of the debate has centered on the legitimacy of the FDA’s classification of personalized genome testing as “medical devices.” But the reasons for the FDA’s action are now being scrutinized. According to a new article, “although the agency is right to sound a warning about 23andMe, it’s doing so for the wrong reasons.”
“At first, 23andMe seemed to angle its kit as a fun way to learn a little genetics using yourself as a test subject,” writes Scientific American‘s Charles Seife. “But as the FDA frets about the accuracy of 23andMe’s tests, it is missing their true function, and consequently the agency has no clue about the real dangers they pose. The Personal Genome Service isn’t primarily intended to be a medical device. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.”
Read the full, original story here: 23andMe Is Terrifying, But Not for the Reasons the FDA Thinks
- “FDA action against 23andMe reveals importance of communication in regulatory process,” Genetic Literacy Project
- “Is the Food and Drug Administration killing personalized medicine?” Reason