When the Food and Drug Administration banned 23andMe from marketing its direct-to-consumer genetic tests nearly two years ago, the company became a cautionary tale of biotech companies: ignore regulators at your own peril.
Since then, 23andMe has changed its tactics, working closely with the FDA, an approach that has slowly born fruit. It received approval to sell a genetic test for markers of Bloom syndrome in February, and today announced bigger news: it will resume sending customers health information collected via mail-in saliva kits.
To be fair, what the company can give to consumers is much more limited in scope than the health information it offered before the FDA shut it down its testing operation in 2013. Back then, it provided customers with their risks of developing up to 254 diseases and medical conditions.
Now, in terms of health information, the company will deal exclusively in "carrier status," i.e. their risk of passing 36 diseases and conditions (including cystic fibrosis and sickle cell anemia) to their children. Each test will also include nonmedical hereditary traits -- such as bitter taste perception, lactose intolerance and cheek dimples – which the company continued to offer even after the FDA intervened.
It's hard to envision anyone but expectant parents shelling out the $199 for this service – but that may be ok. In the interim since the FDA cracked down on its testing operations, 23andMe has pursued additional revenue streams.
Last winter, the company announced that it had sold anonymized genetic data to the biotech firm Genetech and was considering similar deals with other pharma companies (consumers who bought 23andMe kits and agreed to donate their genetic information to research automatically consented to 23andMe sequencing their genomes, Forbes reported at the time).
In May, the startup announced it would begin drug discovery and development itself.
While not as comprehensive as they once were, 23andMe's reinstated ability to market direct-to-consumer genetic tests will likely help on both fronts.
For all the biotech companies watching the saga unfold, 23andMe's cofounder and CEO Anne Wojcicki sent a clear message: “We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing," she said in a statement. "We are a better company with a better product as a result of our work with the FDA."
In other words, don't try and work around the FDA. Because you will get burned.