23andMe Submits FDA Paperwork

Consumer genomics company 23andMe has submitted its first 510(k) application to the US Food and Drug Administration as part of a plan to seek clearance for its Personal Genome Service. The service provides health and ancestry information to users. In a post to the Spittoon blog, the company says "we believe personal genetic data will power a revolution in healthcare. But we also recognize that appropriate oversight of this industry can be a stepping stone on the path to realizing that revolution."

The Sample's sister publication Pharmacogenomics Reporter adds that although 23andMe is seeking FDA clearance, it still plans to offer its services directly to consumers. "23andMe has publicly expressed its willingness to meet FDA regulations, but has also insisted that the agency's oversight shouldn't necessarily preclude consumer access to genetic testing," Turna Ray reports, adding that "the FDA of course could still delineate certain portions of its service as prescription only."