FDA

23andMe Takes First Step Toward FDA Clearance

July 30, 2012
Today 23andMe announced that we’ve submitted our first round of 510(k) documentation to the U.S. Food and Drug Administration (FDA). Being the first in the industry to announce we are actively working toward FDA clearance of our direct-to-consumer service demonstrates our commitment to make personal genetics an integral part of routine healthcare without sacrificing people’s right to access information about themselves.
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Hope in a Pill: New Treatment for Cystic Fibrosis Approved

February 24, 2012
The realization of a long-awaited hope arrived this past month for many families in the form of a new treatment for cystic fibrosis. Cystic fibrosis (CF) is one of the most common recessively inherited diseases, affecting about 30,000 people in the United States. Last month the FDA approved the drug ivacaftor (Kalydeco ®) as the first treatment to address one of the underlying causes of CF.
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The Debate Over Clopidogrel Continues

January 30, 2012
Genetics impacts how quickly people metabolize the commonly prescribed anti-clotting drug clopidogrel (Plavix), but whether genetics affects cardiovascular outcomes of people taking the drug is a subject of debate.
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FDA to Hold Public Town Hall Discussion in San Francisco

August 25, 2011
In March earlier this year, 23andMe presented its views on possible federal regulation of the direct-to-consumer (DTC) genetic testing industry at an Advisory Committee meeting convened by the FDA. We...
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Public Comments Due on Possible FDA Regulation of Direct to Consumer Genetic Testing

April 26, 2011
From its founding 23andMe has made clear its views that people should have a right to access their own genetic information. And in the debate over regulation of direct to...
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DTC Genetic Tests and the Future of Regulation: Make Your Voices Heard

April 04, 2011
On March 8th, the FDA convened a two-day advisory panel meeting to discuss questions related to direct-to-consumer genetic tests. The questions focused on the benefits and risks of providing consumers...
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23andMe Presents at FDA Advisory Panel Meeting on Direct-to-Consumer Genetic Tests

March 08, 2011
Editor’s note: This post has been altered from the original. The slides from the presentation have been removed. 23andMe, like many others, believes that individuals have a right to access...
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23andMe at FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs)

July 20, 2010
The FDA/CDRH Public Meeting on Oversight of Laboratory Developed Tests (LDTs) took place yesterday and today (July 19 and 20) in Washington, DC. Webcasts of both days will be available...
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Update on 23andMe and the FDA

July 12, 2010
On June 10, 2010, 23andMe received a letter from the Food and Drug administration (FDA) expressing the agency’s view that our Personal Genome Serviceâ„¢ may be subject to FDA regulation....
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FDA Adds Boxed Warning to Plavix Label to Highlight Reduced Effectiveness of the Drug In Poor Metabolizers

March 15, 2010
The U.S. Food and Drug Administration (FDA) has updated the label information for the commonly used anti-clotting medication Plavix ® (clopidogrel) to stress to physicians that patients carrying certain genetic...
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