Big news at 23andMe today: The direct-to-consumer genetics company is selling health-related genetic tests again–starting with one category of disorders, autosomal recessive disorders that children can inherit if both their parents are carriers. The new test comes with a higher price tag of $199 for new customers, up from $99 before the FDA told the health startup to stop marketing its genetic health tests two years ago. 23andMe is also unveiling a revamped web experience it hopes will help customers better understand their genetic health reports.
In November 2013, the FDA issued 23andMe a harsh warning letter ordering the company to stop selling health-related tests because it could not document the accuracy of its test results to the agency’s satisfaction. For the last two years, the company could only market tests that tell users about their ancestry.
During this period, cofounder and CEO Anne Wojcicki has worked hard to rebuild 23andMe’s relationship with the FDA by hiring legal and regulatory experts to provide the agency with the documentation required to validate the company’s tests. With this new regulatory infrastructure in place, the FDA has allowed 23andMe to start marketing one category of tests that reveal autosomal recessive disorders–and the two organizations are continuing to work together to possibly bring other health-related genetic tests to market.
Since the FDA letter, 23andMe has also been focused on redesigning its website. The company’s product team has focused on translating highly complex genetic information into terms that are more comprehensible to users, regardless of their background or education level. The new website is therefore less cluttered and clearer than the old one. The stakes of this design challenge are high: 23andMe sells its tests directly to consumers, so most customers will rely entirely on the company’s website to help them interpret their results, without the help of a doctor or a genetics counselor. Their task was made even more crucial because the FDA’s warning letter expressed concern that customers might use their reports to make irreversible medical decisions, like not taking their doctor-prescribed medication, so 23andMe needs to make sure that users understand the personal health reports they read on the website.
But this doesn’t mean the road is all clear for 23andMe. For one thing, it still can’t market all of the genetic health reports it used to test for before the FDA’s letter two years ago. Further, it probably can’t afford to make more mistakes (like its mishandling of its relationship with the FDA) in the future–and thanks to recent controversial reports about direct-to-consumer blood testing company Theranos, health startups like 23andMe are under as much scrutiny as ever.