Genetics Startup 23andMe takes Step on Path to FDA Approval

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June 25, 2014 -The genetics startup 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.

In November of 2013, the Google Inc-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 regulatory attorney with Epstein Becker & Green, said this was an important “milestone” for 23andMe. The process may still take time, he added, as the FDA will likely have further questions or requests for information. “But this does reveal 23andMe’s strategy – and that’s to go through the process with the FDA.” While it awaits the nod from the FDA, the company is looking into approval in overseas markets in Canada, Australia or the United Kingdom, Reuters reported last month. Company spokeswoman Catherine Afarian said the company is “in the process of exploring international opportunities.”

 

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Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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