An FDA decision summary released today 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. In February, the FDA announced it would approved 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.
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