FDA Halts 23andMe Genetic Tests

Finding out whether you’re at high risk of developing Alzheimer’s disease or migraines may become more challenging, at least if you want to do it yourself. The FDA warned 23andMe, a leading genetic-testing company that sells services directly to consumers, that its products need the agency’s approval to stay on the market.

With just a bit of spit, companies like 23andMe, co-founded by Anne Wojcicki and backed by Google, provide a wealth of information about genetic makeup, from an individual’s risk of developing cancer to the ability to respond to drugs like the blood-thinning medication warfarin. (The company also provides a genetic genealogy service.) But the FDA wants more assurance that these results are backed by enough scientific data that patients can rely on them to make decisions about what treatments to choose or which medications to take. That evidence, however, may be a while in coming, since interpreting a person’s genome lags far behind scientists’ ability to map it. Four other genetic-testing companies received alerts about their services in 2011. For now, 23andMe has 15 days to respond to the agency’s requests. All marketing must halt until then.

–A.P.