Recall that, in 2013, 23andMe received warning letters from the FDA to stop its inexpensive (then $99 per test) “do-it-yourself” genetic testing service for health screening and ancestry purposes, because consumers could be “misled” and harm themselves by “self-treating.” It didn’t look like the company was going to survive.
But then it received a major injection of investment from ten major pharmaceutical and biotech companies. At the time, we reported that the idea was to use the tests to help drug companies test new drugs. The move would keep the FDA at bay, and possibly even make the FDA friendly—but it also ensured that future developments will be guided by the interests of the pharmaceutical industry, not the consumers who desperately need these tests. The FDA especially likes that 23and Me might help Big Pharma test its drugs after the repeated failure of expected blockbusters in clinical trials to treat Alzheimer’s.