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A recent FDA decision summary allows DNA-testing company 23andMe to market a genome test that screens for Bloom syndrome, a rare disorder that leads to a predisposition in carriers toward the development of cancer. 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.
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.
Read full, original post: FDA opens door for 23andMe to market some direct-to-consumer genome tests