regulation

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...

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.

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.

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...

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...

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...

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...