An FDA decision summary released today allows DNA-testing company 23andMe to market a genome test that screens for Bloom syndrome, a rare disorder in which carriers are predisposed towards developing cancer. In February, the FDA announced it would approve the Bloom test, but 23andMe was unable to begin marketing these tests until today's detailed regulations and guidelines were announced. While, on the surface, this may seem like a minor change in policy, it is significant given the complex relationship the FDA has had with 23andMe over the last two years.
In 2013, the FDA sent 23andMe a letter ordering it to stop offering its main product, a personal genome service that gave customers insight into whether or not they were carriers for various diseases. According to the FDA, 23andMe had not obtained the correct legal approvals. As a result, 23andMe stopped selling personal genome tests and results in the U.S., but continued to offer a product that allows customers to better understand their ancestry. (The health-related tests continued to be available in Canada and the U.K., where government regulations are different.)
Over the last two years, 23andMe has been working closely with the FDA to discuss how their tests might be federally approved. They focused first on the Bloom test because it was a fairly straightforward genetic condition and the company assumed that it would have to clear one genetic test at a time with the FDA. Today's news allowing 23andMe to move forward with the Bloom test is particularly compelling given that Anne Wojcicki, 23andMe's cofounder and CEO, is a carrier of the disease.
Not only does has the FDA cleared 23andMe's Bloom syndrome report, it also says that the whole category of diseases like Bloom syndrome—autosomal recessive disorders which require one copy of the abnormal gene to be present in each parent in order for the disease to manifest in their child—will no longer require pre-market review. Other diseases in this category include cystic fibrosis and Tay-Sachs disease. The FDA's statement in February announced it's intention to declassify these carrier tests, but today's decision summary clarifies the full scope of tests 23andMe is allowed to market going forward. Currently, 23andMe is still not allowed to issue reports relating to illnesses such as Alzheimer's or Parkinson's, or for BRCA genes that predispose carriers to breast cancer.
Today's decision released by the FDA also includes conditions by which 23andMe's autosomal recessive testing business must comply. The company must adhere with extensive guidelines that require, among other things, that consumers understand what genetic testing entails and the results of their genetic reports. To meet these guidelines, 23andMe will need to educate consumers about the purpose of the genetic tests and teach them how to interpret the reports.
Other U.S.-based DNA testing services will be subject to these same regulations. The FDA's decision could change the competitive landscape for direct-to-consumer genome testing, making it easier for other companies to enter the market and offer health-based genetic tests.