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). The application provides a detailed description of our Personal Genome Service®, extensive data supporting the performance of our technology, and comprehensive discussions of [...]
November 4, 2011
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 [...]
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 reiterated our belief that individuals have a right to access their own genetic information without physician [...]
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 consumer genetic testing, we’ve made our views clear to officials at the Federal Drug Administration (FDA). Have you? May 2nd [...]
April 4, 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 with direct access to these tests, potential strategies for communication and education to mitigate any [...]
March 8, 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 their own genetic information and that personal genetics will pave the way for significant advances in healthcare. [...]
