Last Friday, the Food and Drug Administration issued a warning letter to the direct-to-consumer genetic testing company 23andMe ordering it to stop marketing its Personal Genome Service.
According to the FDA, the 23andMe genetic test is a medical device, and subject to intense regulation before it can be marketed, because “it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.” The FDA’s letter goes on to describe the many instances on the company’s website that refer to 23andMe’s test in terms of diagnostic value.
The FDA’s stated concern is the potential for false positive results, for which they describe dire scenarios that could be taken, as in the case of a false BRCA1 test—which might encourage a woman to erroneously have a preventive mastectomy to avoid cancer. A fact worth noting is that the FDA failed to cite any real examples where an individual harmed him or herself with unconfirmed knowledge of genetic information. The FDA’s stated action was prompted by 23andMe’s failure to clinically validate tests—that is, to show that the genetic irregularities it sees are meaningfully predictive of a person’s future health outcomes.
The regulatory action comes at a crucial time for 23andMe. The company has unveiled a new direct-to-consumer (DTC) marketing campaign, with expanded indications, and use of TV commercials to increase their consumer base to a goal of 1 million users.
Without a doubt, the FDA’s action has already prompted a lively debate. 23andMe has issued a short 53-word statement on its website and the company’s Facebook page that it has received the letter, understand it has not met the FDA’s expectations regarding timeline and communication, and is committed to working with the FDA. Within four hours of 23andMe’s post, 217 comments were received on the company’s Facebook fan page.
The vast majority of commenters, not surprisingly, are supportive of the company and critical of the FDA. Many commenters focused on general distrust with big business (something 23andMe aspires to become) and government. Many others spoke of a desire to be able get their personal genetic information, and others expressed absolute confidence in the results they obtained. Many fewer comments were favorable toward the FDA. Some understood the need to validate diagnostic tests, a few tried to explain the differences between screening and diagnostics, and a few more observed that some of the level of dialogue demonstrated a need for regulation. The biggest concern was by those who recently signed up, and wanted to know if they would get their test results. If you add up all of the likes, shares, and replies, thousands of consumers are interested and engaged.
Of course Twitter was buzzing too, but mostly on stating there was news. A few comments mentioned that 23andMe brought this on itself by going to the FDA in the first place. Thus far, no substantiated stories have appeared that validate the FDA’s alarmist scenarios cited in their letter.
So, is this good policy or an example of regulatory overreach? 23andMe performs their genotyping test using a well-characterized platform (the Illumina HumanOmniExpress chip) in a CLIA-certified laboratory. The 23andMe results meet the standards of any other laboratory-developed test. This weakens the FDA’s main argument that
