Genetics start-up 23andMe said on Friday it is one step closer to resuming sales of its full-fledged health product, with the U.S. Food and Drug Administration accepting its first health report for review. The home genetics company said in a blog post that the FDA will begin evaluating the company's submission for a 510(k) application, a regulatory process that applies to most medical devices sold in the United States. Kathy Hibbs, 23andMe's chief legal and regulatory officer, said in the blog post that the submission focused on one single inherited condition, called Bloom Syndrome. "Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions,'' Hibbs writes. Read More 3 promising tech darlings that fell flat In November of 2013, the Google-backed firm stopped selling its $99 DNA test until it obtained marketing authorization from the FDA. 23andMe had previously said in its marketing materials that it could deliver insights about people's genetic predispositions toward "254 diseases and conditions.'' But in a public warning letter last November, addressed to 23andMe's chief executive Anne Wojcicki, the FDA expressed concerns about the "public health consequences of inaccurate results'' from 23andMe's genetic test kit. Bradley Merrill Thompson, a product … Continue reading
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