US Department of Health threatens 23andMe

The FDA (Food and Drug Administration) at the US Department of Health and Human Services published a letter to the executive director of startup 23andMe Ann Voichicki with a warning about the legal consequences of not following the prescribed action.

Officials warn that the analysis of personal genomes is a medical activity, and working without a permit is in violation of the Federal Food, Drug and Cosmetic Act (FD & C Act). In particular, the company offers personal genotyping service (PGS), within which it provides an individual report on the presence or absence of 254 diseases and conditions, including in the thematic categories “hereditary diseases”, “health risks” and “reaction to drugs” . At the same time, PGS is positioned as a means for early warning of the risk of serious diseases such as diabetes, coronary heart disease, breast cancer. DNA analysis helps to find unknown relatives, determine the genealogy, get new information about their genetic markers as they are deciphered by the scientific community.

The FDA believes that most uses of PGS indicate that a container for taking samples of saliva is a medical device, and genotyping is a medical service. Such devices and services require FDA approval.

Recently, FDA employees have tried several times to contact 23andMe to resolve a problem, but did not receive a response. Therefore, the FDA warns that if the company continues to operate without a permit and does not make the necessary changes to the description of the containers for saliva samples, then this may trigger “appropriate corrective actions” without prior notice. Among possible actions, the FDA cites property confiscation, an injunction and monetary fines.
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Founded in 2006, the company 23andMe has already attracted more than $ 160 million in venture financing from the largest investors in Silicon Valley, including from Google and from Sergey Brin's personal funds. Judging by open sources , 23andMe is one of only two startups in which Sergey Brin has invested his own money.

It is known that last year the company 23andMe sent requests to the FDA to conduct seven tests . This year, additional requests were sent, but still this is only a small part of the 254 tests that are carried out within the PGS.

Experts disagree on the value of information provided by 23andMe as part of its service. Some believe that the analysis of 1 million of 3 billion genes (snaps) is not able to give any valuable recommendations for a healthy lifestyle that would be more useful than the usual advice of a therapist to eat right, do not smoke and move a lot.

In principle, the company 23andMe has options on how to bypass the FDA restrictions. The fact is that this company itself is not engaged in genotyping. This is a purely IT company that works only with information. OraSure Technologies is engaged in the production and distribution of containers for saliva to the users who paid $ 99. On each container - a unique bar code. People send sample containers directly to Laboratory Corporation of America (LabCorp) for processing. In turn, LabCorp for contracting genotyping uses Illumina HumanOmniExpress-24 chip devices on a contract basis. The results in electronic form are sent to 23andMe, where they are tied to a user account created during the registration on the site using a barcode.

The FDA letter says that the main reason why the agency wants to control the activities of 23andMe is the risk of falsely positive and falsely negative diagnoses (a good example ). Such information may push the user to undergo treatment or, conversely, reassure the person - and he will refrain from going to the doctor. At the same time, the terms of the 23andMe agreement expressly indicate that the result of genotyping is not a diagnosis, information is provided only for reference purposes and should not affect a person’s medical behavior.

Yesterday, 23andMe published an official statement in connection with the FDA letter, in which they recognized the importance of the procedures for obtaining permits and promised to work more actively with the FDA in the future.