In historic reversal, FDA approves 23andMe genetic test for Bloom Syndrome
- The FDA on Thursday authorized marketing of 23andMe's genetic test for Bloom Syndrome, a serious rare genetic disorder that can lead to stunted growth and increased cancer risk which mostly afflicts people with Ashkenazi Jewish heritage.
- The agency's decision marks a significant reversal from just one year ago, when the FDA sent 23andMe a stern warning letter regarding the legality (or illegality) of its Personal Genome Service, forcing the company to stop offering the wide-ranging genetic tests.
- It's still unclear just how much of a sea change this heralds for the broader direct-to-consumer genetic testing market. But the FDA did announce that it "intends to exempt these [carrier screening test] devices from FDA premarket review"—a pretty big deal in an of itself.
It'll take some time before we know just how far-reaching the FDA's decision will be, since it only authorizes one specific 23andMe test at this point. But the company's CEO, Anne Wojcicki, wrote in a blog post that it was welcome (though far from perfect) progress.
"Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers in the US," wrote Wojcicki.
"This is also the first-time the FDA has granted authorization to market a direct-to-consumer genetic test, and it gives 23andMe a regulatory framework for future submissions. 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."