Genetics Startup 23andMe takes Step on Path to FDA Approval

Last Updated on

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.”


Tags: , , , ,
About the Author
thassodotcom 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.

Leave a Reply

Optional: Social Subscribe/Login

Notify of

thasso: conditions

thasso: tweets

thasso post: magazine

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • Ancestry launches DNA health service that will compete with 23andMe October 15, 2019
    Ancestry has long appealed to people eager to learn about their family roots. Now the company known for its popular DNA kits is diving into a new area of discovery—health.
  • Improving research with more effective antibodies October 15, 2019
    A new study points to the need for better antibody validation, and outlines a process that other labs can use to make sure the antibodies they work with function properly.
  • New DNA 'clock' could help measure development in young children October 15, 2019
    Scientists have developed a molecular "clock" that could reshape how pediatricians measure and monitor childhood growth and potentially allow for an earlier diagnosis of life-altering development disorders.
  • DNA fracturing rewires gene control in cancer October 15, 2019
    Understanding the mechanisms that mediate widespread DNA damage in the cancer genome is of great interest to cancer physicians and scientists because it may lead to improved treatments and diagnosis. In this study, a multi-institutional team led by researchers at Baylor College of Medicine has brought attention to genomic structural variation as a previously unappreciated […]
  • Most genetic studies use only white participants – this will lead to greater health inequality October 15, 2019
    Few areas of science have seen such a dramatic development in the last decade as genomics. It is now possible to read the genomes of millions of people in so-called genome-wide association studies. These studies have identified thousands of small differences in our genome that are linked to diseases, such as cancer, heart disease and […]