FDA Warns 23andMe

The FDA has sent a letter to a company called 23andMe, warning the company to stop selling its popular genome testing service to directly to consumers. For just $99, the company had been promising to analyze samples of saliva for nearly 300 different gene alleles, many of which are associated with increased risks of known genetic diseases.

People certainly have the right to their genetic information if they wish. The problem is that because the results could indicate that the person may be at an increased risk for specific genetic diseases, the results are more like medical tests than just interesting information, meant to satisfying ones curiosity. Any references to increased risks of genetic diseases associated with the results are tantamount to medical advice. The FDA is concerned that people may make medical or life-style decisions based on the unproven tests and unknown or inaccurate risk assessment. Risk of genetic disease, for example, may depend on family history and environmental factors, in addition to just the genetic component. Discussions of risk generally include a thorough medical history and discussion with a physician or genetic counselor, all of which are lacking when a test (and subsequent risk assessment) is done by mail order.

There are companies, such as dna.ancestry.com, that offer to test your DNA so that you can trace your ethnic origins or potentially identify specific ancestors. That’s not an issue for the FDA because it is essentially for entertainment, not medical diagnosis.