The future of genetic testing entered some rocky territory in the last two weeks when startup 23andMe was warned by the FDA that should stop making health-related claims with its signature $99 test, something the company was not authorized to do. The FDA and 23andMe had apparently been communicating until about six months ago, when the company abruptly stopped responding to the regulator. On November 22, the FDA had had enough, and sent a stern letter to the startup warning them to stop making the claims.
Yesterday, 23andMe acquiesced, announcing they would continue selling their test, but that the results for tests sold after November 22 would be limited to ancestry and raw data. The health-related claims, which included risks for certain diseases based on a person’s genetic makeup, would no longer be included.
Matthew Herper, writing for Forbes:
The decision seems to indicate that 23andMe’s conflict with the FDA wasn’t a planned move to try and change policy or set off a legal maneuver, as some fans and defenders of the company hoped, but simply a mis-step. The FDA said in its warning letter that 23andMe had gone quiet for six months, at the same time making more health-related claims for its test, including a video on its Web site in which a patient and her doctor testified that the 23andMe kit helped her learn she had celiac disease, a digestive disorder.
23andMe’s decision to stop making health-related claims doesn’t spell an end for the test—nor does it signal the death of personal genome testing. Rather, the company and others hoping to jump into the field will have to prove that their tests are reliable and that medical research supports the claims they make based on a person’s test results. In other words, they have to clear the same bar as other medical tests.
The FDA has shown a willingness to help 23andMe, so if the company can keep its head down and complete the necessary trials, it’s likely that personal genetic testing will have a bright future.