Last summer, the Food and Drug Administration (FDA) indicated that it would be revising its regulatory guidelines pertaining to laboratory-developed tests (LDTs), and that direct-to-consumer genetic tests such as 23andMe’s Personal Genome Service ® would potentially fall under that category. 23andMe has historically taken an active role in communicating with the FDA about our service and the last eight months have been no exception. We believe that individuals have a right to access their genetic information and to understand what they are getting. As a result, we support appropriate regulatory frameworks in the complex and dynamic field of genetic testing and have been putting our efforts towards solutions.The FDA held a public hearing on LDTs on July 19-20, 2010 and will be following that up next month with a public Advisory Committee meeting to be held March 8-9. This meeting will discuss issues surrounding direct-to-consumer access to genetic testing, including the risks and benefits of direct access, potential for misinterpretation or miscommunication, and standards of evidence for information provided to consumers. 23andMe will be attending this meeting and plans to submit a presentation outlining our views on these issues.We encourage everyone to make their opinions on this important topic known to the FDA by submitting comments by the March 1, 2011 deadline. Interested parties may submit written presentations until February 23, 2011 or proposals for formal oral presentations until February 15, 2011.
- Electronic comments can be submitted to: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0066-0001
- Written comments can be sent to: Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852
- Submissions for oral presentations should be sent to: James Swink Center for Devices and Radiological Health Food and Drug Administration 10903 Hampshire Ave Silver Spring, MD 20993-0002
All comments and submissions should be identified as being with regard to Docket No. FDA-2011-N-0066.