Up until that point, the company had been analyzing consumers’ personal genomes, sent via mail-in spit kits, in order to provide detailed summaries of their genetic risk for a host of common diseases; with the FDA’s ban, overnight the company became a glorified version of Ancestry.com.
Now, the FDA is easing its position, if ever so slightly, having granted 23andMe permission to sell a genetic test for makers of Bloom syndrome, a rare genetic disorder characterized by sun-sensitivity, short stature and an increased risk of cancer.
As 23andMe cofounder Anne Wojcicki notes in a blog post announcing the news, this marks the first time the FDA has approved the marketing of a “direct-to-consumer” genetic test. Taken alone, it’s a small step, but it is also points to a possible larger shift in the way the FDA may approach the marketing of additional tests for genetic diseases in the future.
The FDA’s decision “gives 23andMe a regulatory framework for future submissions,” Wojcicki writes. “While this authorization is for a single carrier status test only, we are committed to providing US customers with health information once more tests have been through this process and we have a more comprehensive product offering.”