23andMe Complies With FDA Directive; Company Halts DTC Health-Related Genomic Analysis

Thirteen days after receipt of a warning letter from the U.S. Food and Drug Administration (FDA), 23andMe (Mountain View, Calif.) announced it will stop offering its health-related genetic tests while the company moves forward with the regulatory review process. The FDA warning and the company’s handling of the regulatory process have both drawn criticism, raising speculation as to the future of both 23andMe and the broader direct-to-consumer (DTC) genetic testing industry.

The FDA’s Nov. 22 warning letter contends 23andMe’s saliva collection kit and Personal Genome Service (PGS) is a class III medical device, which was being marketed without appropriate clearance or approval. The agency has withdrawn 23andMe’s previously submitted 510(k)s for the PGS in response to the company’s failure to address issues outlined in previous discussions with the agency.

“I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future. Our goal is to work cooperatively with the FDA to provide that opportunity,” wrote Anne Wojcicki, 23andMe’s CEO, in a Dec. 5 blogpost.

In a statement 23andMe said it will continue to provide ancestry-related genetic tests and raw genetic data, without interpretation. Existing customers before Nov. 22 will retain access to health-related information, but all customers who purchased kits on Nov. 22 or afterward will only have access to the limited testing and are eligible for a refund. Wojcicki adds that research will remain “a significant priority” for the company, which plans to launch more research communities in 2014.

In light of the trend toward increasing consumerism in the laboratory industry, please read more about 23andMe and the future of DTC genetic testing in Inside the Diagnostics Industry on page 5.


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