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23andMe Submits Documents for 510(k) Clearance from FDA

NEW YORK (GenomeWeb News) – 23andMe today announced that it has started the process for regulatory clearance of its Personal Genome Service.

The Mountain View, Calif.-based consumer genetics testing firm said it has submitted its first round of 510(k) documentation to the US Food and Drug Administration, addressing concerns on the agency's part about tests such as those offered by 23andMe that are marketed directly to the public.

The de novo 510(k) application 23andMe submitted this week represents the first of several the company plans to file this year with the FDA related to its Personal Genome Service. The first submission, made to the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health, included information about seven genetic tests that are included as part of its service.

"23andMe has always valued the guidance of the FDA and, in fact, engaged the agency in conversations prior to launching the Personal Genome Service in 2007," Ashley Gould, company VP of corporate development and chief legal officer, said in a statement. "Our ongoing conversations with the FDA in the last year, in particular, resulted in a focused approach that resulted in our ability to compile a comprehensive analysis of 23andMe's direct-to-consumer testing for FDA consideration."

The firm is the first of the DTC genetic testing companies to submit to FDA for regulatory clearance of its services. In 2011, the agency sent out letters to a number of such firms, including 23andMe, warning them that their services appeared to qualify as medical devices and required FDA clearance or approval.

In a post on 23andMe's blog, The Spittoon, the company said today that it continues to believe that consumers "have a fundamental right to their personal genetic data" and that the 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 company also said that it has worked with FDA for the past three years "to apply their regulatory approach to direct-to-consumer genetic testing" and that a regulatory framework for such testing reflects "the dynamic nature of genetic science and protect[s] individual access."

The Personal Genome Service provides more than 200 health and trait reports and genetic ancestry information. A company spokesperson said that 23andMe is seeking FDA clearance only for its health and trait reports, as the ancestry tools are not considered in vitro diagnostics by FDA.

For more details on 23andMe's filings and plans see GWDN sister publication Pharmacogenomics Reporter.