ACMG Guidelines at Odds With FDA Green Light for 23andMe Health Risk Tests

The top organization in the US responsible for developing genetic testing guidelines is not on board with the US Food and Drug Administration's decision last week to allow 23andMe to sell genetic health risk tests online directly to consumers.

"The announcement that the FDA intends to allow direct-to-consumer access to genetic risk prediction tests when the results are presented in a way that isn’t specific to an individual’s own medical and family history has significantly changed the landscape of genetic testing," the American College of Medical Genetics and Genomics said a statement last week. Through 23andMe, consumers will gain an incomplete picture of their genetic predisposition for serious diseases, such as Alzheimer's, ACMG warned, and this could fuel follow-on testing or inspire self-directed changes.

Detractors of personal genomics companies like 23andMe have long worried that that the follow-on testing will be unnecessary and result in wasteful spending, and that the self-directed changes, like taking nutritional supplements or making dietary changes, may even cause harm.

It's hard to balance the value of these tests against potential risks, ACMG CEO Michael Watson...