The direct-to-consumer (DTC) genetic testing business hit a major speed bump when the Food and Drug Administration (FDA) stopped 23andMe in its tracks two years ago. The FDA asserted control over the sale of DTC tests, saying that it required proof of their analytical or clinical validity.
At the time, this was controversial, with libertarians particularly up in arms about “bureaucrats” and “ridiculous bans.” Others pointed out that the FDA was doing its job. Matthew Herper in Forbes (or his editor) came up with the headline:
23andStupid: Is 23andMe Self-Destructing?
We now have a definitive answer: No. From the same author, same publication, already online, and in print on November 2:
23andMe Wins A Second Life: New Business Plan Scores $115 Million From Investors
The latest investment, from several venture capital outfits, values the company at $1.1 billion.
A company spokesperson told The Verge that they “will return health reports to consumers by the end of this year.” Back in February, the FDA did give the company clearance to sell a test for one specific gene correlated to a rare genetic disease, and CEO Anne Wojcicki is spinning that hard:
Now Wojcicki says she hopes the FDA will allow 23andMe to market some health-related tests again soon. “There’s a huge value in actually being the only one who’s gone through the FDA process and can sell directly to consumers,” she says. Some of them, she hints, may have higher margins than the $99 test.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.