FDA Halts 23andMe Personal Genetic Tests

Direct-to-consumer (DTC) genetic testing gained notoriety in the autumn of 2008. That was when two prestigious publications, The New Yorker and The New York Times, featured largely positive accounts of a celebrity “spit party”—at which notables dressed in cocktail attire ejected their saliva into test tubes for genetic analysis.1,2

That trendy gathering seemed to be the leading edge of a new era of personalized medicine. Companies selling saliva kits online promised that the tests would give customers medically crucial information about risks for a wide range of diseases. Some observers enthused that DTC gene tests would revolutionize medical care.

But at least to date, the reality has fallen far short of such claims.

One major setback for the DTC gene test industry came in 2010, when the Government Accountability Office (GAO) issued a stinging report3 after it had submitted identical DNA samples to four DTC gene testing companies and gotten back contradictory results. The GAO’s report called DTC gene tests “misleading and of little or no practical use.” The same year, when Pathway Genomics tried to sell a DTC...