regulation

Discussion On Faster Cures

June 24, 2014
(Editor’s note: This post was edited from the original.) This week 23andMe CEO and co-founder Anne Wojcicki participated in a roundtable discussion held by the US House Energy and Commerce...
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23andMe Provides An Update Regarding FDA’s Review

December 05, 2013
By Anne Wojcicki After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic...
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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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Support Your Right to Access Your Clinical Lab Results

November 04, 2011
In September, Secretary of the U.S. Department of Health and Human Services Kathleen Sebelius proposed rules to give patients direct access to their clinical laboratory results. We believe that giving people access to their lab results will trigger more engagement by patients and better dialogue between patients and their doctors. Your comments may help make a difference between whether the proposed rules become reality.
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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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