Tag: regulation

23andMe Provides An Update Regarding FDA’s Review

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 tests while the company moves forward with the agency’s regulatory review processes. 23andMe has ...

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23andMe Takes First Step Toward FDA Clearance

Today 23andMe announced that we’ve submitted our first round of 510(k) documentation to the U.S. Food and Drug Administration (FDA). The application provides a detailed description of our Personal Genome Service®, extensive data supporting the performance of our technology, and comprehensive discussions of ...

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Support Your Right to Access Your Clinical Lab Results

Giving people access to their genetic information is what we are about at 23andMe. We believe that it is not just a fundamental right, but, as with access to all of your health records, it is vital to making informed decisions about your wellbeing. That is why 23andMe is so encouraged by statements coming ...

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FDA to Hold Public Town Hall Discussion in San Francisco

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 reiterated our belief that individuals have a right to access their own genetic information without physician ...

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Public Comments Due on Possible FDA Regulation of Direct to Consumer Genetic Testing

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 consumer genetic testing, we’ve made our views clear to officials at the Federal Drug Administration (FDA). Have you? May 2nd ...

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DTC Genetic Tests and the Future of Regulation: Make Your Voices Heard

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 with direct access to these tests, potential strategies for communication and education to mitigate any ...

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23andMe Presents at FDA Advisory Panel Meeting on Direct-to-Consumer Genetic Tests

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 their own genetic information and that personal genetics will pave the way for significant advances in healthcare. ...

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