Picture murky: 23andMe and the FDA

Genetic testing company 23andMe seems to be in no rush to resolve its differences with the FDA, and the digitalhealtherati a/k/a D3H (Digital Health Hypester Horde) are wondering why. In late November, 23andMe executives undoubtedly had a depressing Thanksgiving when the FDA ordered them to stop providing health reports (interpretation of genetic results) and marketing kits. Four months later, 23andMe continues to sell its kits for $99, providing only raw genetic data and ancestry reports–and according to its 31 March blog posting, will do so for the foreseeable future as they complete the regulatory review process. The blog quoted CEO and co-founder Anne Wojcicki, “My main priority is resolution with the FDA,” but actions speak louder than words–and the FDA isn’t talking. The FDA standard is still validation–the company has to analytically and clinically validate 23andMe for its intended uses, which is why the FDA took action against them in the first place.

  • Is the lack of urgency more about continuing to gather raw genetic and health data unimpeded? Ms Wojcicki had widely stated her real aim was to build a 25-million-strong database (Fast Company).
  • Is the real revenue stream of the company not the kits but in monetizing a massive database, selling it to researchers and others (Matthew Herper in Forbes)–the Google model which Ms Wojcicki is quite familiar with? Consider that there’s $126 million into the company, that is a lot of $99 kits.

Most companies in this situation would be imploding. This one is not. Interestingly. FierceMedicalDevices, The Verge

Previously in TTA: all you ever wanted to know about the 23andMe kerfuffle in FDA tells 23andMe genomic test to stop marketing (including this Editor’s analysis of their pre-FDA website with copy breathlessly expressing potentially life-saving or critical lifestyle changing claims, countered by legal ‘educational use’ boilerplate) and The inevitable: class action lawsuit against 23andMe (a check of the Ankcorn blog has no updates)

Categories: Latest News and Opinion.


  1. Don Logue

    Possibly a smart workaround strategy in the works. I have not yet purchased a kit, so I do not know the content of the results, but the courts are ruling in favor of consumers when it comes to access to their lab data and other records. What would prevent the consumer from taking raw results data to any third party worldwide for interpretation? FDA continues to be serious bottleneck driving innovation offshore for development.

  2. Donna Cusano

    Don, that is the exact view I’d have from the consumer POV, but what they are also working around is any kind of outside measure of effectiveness. This is genetic data we are talking about here and do you really want potentially bad information without any oversight? As a company, I would think 23andMe would want this type of approval, but they don’t seem to be pursuing.

    However, are you as sympathetic to their building a database and selling your information?