23andMe, Inc.

We support the Subcommittee and FDA in the effort to create an improved regulatory framework for genetic testing. We are already working with FDA, NIH, and other organizations to strengthen regulations for all laboratory testing, including genetic testing. Indeed, we first met with the FDA in 2007, before we ever offered our service to consumers. Thereafter, in 2008, we met with FDA Commissioner von Eschenbach and his staff, and they encouraged us to proceed. We have had ongoing discussions with FDA since that time. Tomorrow, we will present our regulatory proposal to the FDA. Our plan takes ...


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