The FDA backs a market that lets consumers easily gain information about their genomes and genetic risks, an agency official said, despite aggressive action that stopped 23andMe from selling its direct-to-consumer health-related genetic tests until they obtain formal regulatory approval.
Rather than curtailing the budding industry, Courtney Lias of the FDA's Office of In Vitro Diagnostics and Radiological Health told FierceMedicalDevices via email that the FDA supports direct-to-consumer genetic tests that convey health information as long as they're safe.
"The FDA appreciates that many consumers would like to be informed about their genomes, and their genetic risk for development of future disease. We concur that access to tests through a [direct-to-consumer] model can allow consumers to take responsibility for certain aspects of their health and to learn more about genetics and its contribution to risk, among other probable benefits," Lias said. "We thus believe that certain types of tests are appropriately offered through DTC offerings, but find that other types may have risks that cannot be adequately mitigated for DTC use, i.e. we believe that the probable risks may outweigh the probable benefits."
In the case of 23andMe, on Dec. 5 the company capitulated to demands the FDA outlined in its Nov. 22 warning letter to stop selling health-related genetic tests while it submits them for a formal regulatory review. Customers who bought 23andMe's Personal Genomic Service saliva-based tests on or after Nov. 22 will now only gain access to ancestry-related genetic information and raw genetic data. (Customers who signed up before that date can still access their full results.)
In its warning letter, the FDA outlined attempts to bring 23andMe under regulatory oversight since 2009, and Lias reiterated that long process in her comments to FierceMedicalDevices.
"The agency has been working with 23andMe and has provided extensive feedback regarding the information it needs to submit to obtain marketing authorization," she said. "Despite numerous requests, the company has failed to submit the information requested by the FDA, putting consumers at risk of receiving inaccurate information that could result in delayed or inappropriate medical care."
CEO Anne Wojcicki, in a blog post on the company's website, said her company wants to work cooperatively with the FDA to reach a positive outcome, but she also stood by 23andMe's data, standards, and the high accuracy rate of the tests offered by the company.
Lias noted that the FDA has long regulated in vitro diagnostic tests if they give consumers health information (such as pregnancy tests), and manufacturers have generally accepted that practice, even before genetic tests came into the picture.
"The manufacturers of those tests have always accepted FDA regulation," she said. "The agency recently issued a guidance on mobile medical applications which details regulations of other devices that also provide health-related information. That guidance and the current action [with 23andMe] are aligned."