23andMe makes personal genetic tests for users. Disagreements with the FDA (U.S. Food and Drug Administration – Food and Drug Administration) began in 2010, when the first warning was sent. In 2013, 23andMe was forced to shut down health data for users.
What the new FDA solution means for the company and the industry as a whole, today the “Atlas” will tell.
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The first personal genetic tests
The company 23andMe was founded in 2006. One of the first, she began to provide services for the interpretation of genetic data for users. In 2007, the company began selling genetic tests for self-use. To pass the test, there was no need for an official prescription from a geneticist, just order an online test. The user received a tube to collect saliva, filled it and sent to the laboratory 23andMe. There, genotyping was conducted, according to the results of which data on the risks of diseases, peculiarities of digestion and sport activity, history of origin were loaded into the personal cabinet.
The focus of 23andMe was to determine the risks of diseases and carrier status. In 2008, the list of risks consisted of 90 diseases, their number continued to grow. Growing and selling the test, and with it – the attention of the state regulator, the FDA. Apogee fell in mid-2013, when 23andMe launched an advertising campaign on federal television.
Disputes with the FDA and the Department of Health
The first letters from the State Department of Health of New York and California 23andMe received in 2008. The claim was that the company provides medical services (performs saliva tests) without the necessary license. 23andMe replied that the information provided was not diagnostic and only served for educational purposes. A hot discussion in the media unfolded, and the official request came to the back burner. In the same year, 23andMe companies extended the license to sell personal genetic tests in California.
Discussions resumed in two years, when the FDA joined the discussion. The first warning 23andMe received in 2010, and until 2013 the conflict retained the status of official correspondence, in which 23andMe behaved quite carelessly and for half a year delayed with an answer.
As a result, in November 2013, the FDA suspended the sale of the 23andMe tests. The basis was not even the very fact of providing data on health and no doubt about their accuracy. Management was concerned about the potential for patients to take independent action, based on data on predispositions to diseases and individual dosages of drugs. According to the FDA, such actions can damage the health of patients and are unacceptable without the participation of medical specialists. Management particularly worried about the risk of breast cancer, an incorrect assessment of which could lead to preventive mastectomy (removal of the breast).
The section on health at that time totaled 254 signs.
In response to the prescription, 23andMe suspended the sale of tests, returned some users funds and hid the health data from their personal cabinet. There was only an opportunity to download raw data, see data on genetic origin and “entertaining” signs: type of earwax, the smell of asparagus in urine, etc.
In Europe and Canada, users of 23andMe continued to receive data on the effect of genetics on Their health.
Finding solutions to problems and obtaining permits
A long process of certification of health data in the FDA has begun. In February 2015, 23andMe received permission to show the status of carrier of the Bloom syndrome. To do this, the company confirmed the accuracy of the analysis and conducted usability testing, which confirmed that users are able to correctly evaluate the result. In October of the same year, 36 more carrier statuses were added. This was a definite breakthrough, but not yet a complete victory: the approval touched the carrier status, but the data on the influence of genetics on the risks of multifactorial diseases were so far closed to users.
The more significant the achievement of this year: on April 6, 23andMe received permission to display 10 more signs, among which are risks of multifactorial diseases, including Alzheimer’s disease and Parkinson’s disease. These diseases used to cause the greatest number of doubts: at the moment there is no effective treatment of these diseases, and many are inclined to perceive high-risk data as a sentence. Therefore, the positive decision of the FDA for these signs indicates the assurance of the Office that users are able to adequately assess the information even without accompanying the doctor.
Although 23andMe always insisted that users can make independent informed decisions about their health, A new version of the health section has recommendations to consult a geneticist. At the same time, nothing has changed either in the testing technology itself or in the principles of information display – just this time 23andMe did more to get the official permission of the FDA.
Why this story is important for us in Russia
With certain reservations, the FDA agreed to change its tough stance regarding the risks of diseases: and now the data do not need to be received in the presence of a geneticist. At the same time, 23andMe did not have to radically change its position: in 2008, and in 2013, and in 2015, the company insisted that users are able to work independently with the data of the genetic test.
At the same time, the company recognized that users often need advice genetics. We also agree with this in the Atlas – since the launch of our genetic test it includes free consultation with a geneticist.
The official approval of the FDA is important for all companies that conduct genetic testing. The Food and Drug Administration is openly saying that this is not a single solution. A similar scheme for obtaining permission can be used by other companies that do genetic tests for users.
