FDA allowed 23andMe to show risks of ten diseases
On April 6, 2017, the American company 23andMe received permission from the FDA to expand its health data. Now the company can show users information on the genetic risks of ten diseases, including Alzheimer's and Parkinson's.
23andMe does personal genetic tests for users. Disagreements with the FDA (US Food and Drug Administration - Food and Drug Administration) began in 2010, when the first warning was sent. In 2013, 23andMe was forced to close health data for users.
What does the new FDA solution mean for the company and the industry as a whole, today Atlas will tell .
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23andMe was founded in 2006. One of the first, she began to provide genetic data interpretation services for users. In 2007, the company began selling genetic tests for independent use. To pass the test, you did not need a referral from a geneticist; you just need to order a test online. The user received a tube for collecting saliva, filled it and sent it to the laboratory 23andMe. There was carried out genotyping, according to the results of which data on the risks of diseases, peculiarities of metabolism and sports activity, history of origin were uploaded to a personal account.
The focus of 23andMe was on the identification of disease risks and carrier status. In 2008, the list of risks consisted of 90 diseases, their number continued to grow. Test sales also grew, and with it attention from the state regulator, the FDA. The apogee fell in the middle of 2013, when 23andMe launched an advertising campaign on federal television.
23andMe received the first letters from the New York and California Department of Health in 2008. The claim was that the company provides medical services (saliva testing) without the necessary license. 23andMe replied that the information provided is not diagnostic and is for educational purposes only. There was a heated discussion in the media, and the official request faded into the background. In the same year, 23andMe extended the license to sell personal genetic tests in California.
Discussions resumed two years later 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 rather carelessly and for half a year were slow to respond.
As a result, in November 2013, the FDA suspended the sale of 23andMe tests. The reason was not even the fact of the provision of data on health and no doubt of their accuracy. The management was concerned about the potential for patients to take independent actions, based on data on susceptibility to diseases and individual dosages of drugs. According to the FDA , such actions can harm the health of patients and are unacceptable without the participation of medical professionals. The management was 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 consisted of 254 signs.
In response to the prescription, 23andMe suspended the sale of tests, returned funds to some users and hid health data from a personal account. There was only an opportunity to download raw data, to look at data on a genetic origin and "entertaining" signs: type of ear wax, asparagus smell in urine and others.
At the same time, in Europe and Canada, 23andMe users continued to receive data on the effect of genetics on their health.
The long process of certification of health data to the FDA has begun. In February 2015, 23andMe received permission to show the carrier status of Bloom syndrome. To this end, 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, another 36 carrier statuses were added . It was a definite breakthrough, but not yet a complete victory: the approval affected carrier status, but data on the effect of genetics on the risks of multifactorial diseases were still closed to users.
This year’s achievement is all the more significant: on April 6, 23andMe received permission to show 10 more signs, including the 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 for these diseases, and many tend to perceive the data on increased risk as a sentence. Therefore, the FDA's positive decision for these signs indicates the Office’s confidence that users are able to adequately evaluate the information, even without a doctor’s accompaniment.
Although 23andMe has always insisted that users can make independent informed decisions about their health, in the new version of the health section there are recommendations to consult a geneticist. At the same time, nothing has changed in the testing technology itself or in the principles of displaying information - just this time, 23andMe made more efforts to get official FDA approval.
With certain reservations, the FDA agreed to change its tough position on the risks of disease: and now the data do not have to be obtained 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 genetic counseling. We agree with this in the Atlas - since the launch of our genetic test it includes a free consultation with a geneticist.
Official FDA approval is important for all companies that conduct genetic testing. The Food and Drug Administration has openly said that this is not an isolated solution. A similar scheme for obtaining permission can be used by other companies that make genetic tests for users.
23andMe does personal genetic tests for users. Disagreements with the FDA (US Food and Drug Administration - Food and Drug Administration) began in 2010, when the first warning was sent. In 2013, 23andMe was forced to close health data for users.
What does the new FDA solution mean for the company and the industry as a whole, today Atlas will tell .
')
The first personal genetic tests
23andMe was founded in 2006. One of the first, she began to provide genetic data interpretation services for users. In 2007, the company began selling genetic tests for independent use. To pass the test, you did not need a referral from a geneticist; you just need to order a test online. The user received a tube for collecting saliva, filled it and sent it to the laboratory 23andMe. There was carried out genotyping, according to the results of which data on the risks of diseases, peculiarities of metabolism and sports activity, history of origin were uploaded to a personal account.
The focus of 23andMe was on the identification of disease risks and carrier status. In 2008, the list of risks consisted of 90 diseases, their number continued to grow. Test sales also grew, and with it attention from the state regulator, the FDA. The apogee fell in the middle of 2013, when 23andMe launched an advertising campaign on federal television.
Disputes with the FDA and the Department of Health
23andMe received the first letters from the New York and California Department of Health in 2008. The claim was that the company provides medical services (saliva testing) without the necessary license. 23andMe replied that the information provided is not diagnostic and is for educational purposes only. There was a heated discussion in the media, and the official request faded into the background. In the same year, 23andMe extended the license to sell personal genetic tests in California.
Discussions resumed two years later 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 rather carelessly and for half a year were slow to respond.
As a result, in November 2013, the FDA suspended the sale of 23andMe tests. The reason was not even the fact of the provision of data on health and no doubt of their accuracy. The management was concerned about the potential for patients to take independent actions, based on data on susceptibility to diseases and individual dosages of drugs. According to the FDA , such actions can harm the health of patients and are unacceptable without the participation of medical professionals. The management was 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 consisted of 254 signs.
In response to the prescription, 23andMe suspended the sale of tests, returned funds to some users and hid health data from a personal account. There was only an opportunity to download raw data, to look at data on a genetic origin and "entertaining" signs: type of ear wax, asparagus smell in urine and others.
At the same time, in Europe and Canada, 23andMe users continued to receive data on the effect of genetics on their health.
Finding solutions to the problem and getting permission
The long process of certification of health data to the FDA has begun. In February 2015, 23andMe received permission to show the carrier status of Bloom syndrome. To this end, 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, another 36 carrier statuses were added . It was a definite breakthrough, but not yet a complete victory: the approval affected carrier status, but data on the effect of genetics on the risks of multifactorial diseases were still closed to users.
This year’s achievement is all the more significant: on April 6, 23andMe received permission to show 10 more signs, including the 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 for these diseases, and many tend to perceive the data on increased risk as a sentence. Therefore, the FDA's positive decision for these signs indicates the Office’s confidence that users are able to adequately evaluate the information, even without a doctor’s accompaniment.
Although 23andMe has always insisted that users can make independent informed decisions about their health, in the new version of the health section there are recommendations to consult a geneticist. At the same time, nothing has changed in the testing technology itself or in the principles of displaying information - just this time, 23andMe made more efforts to get official FDA approval.
Why is this story important to us in Russia?
With certain reservations, the FDA agreed to change its tough position on the risks of disease: and now the data do not have to be obtained 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 genetic counseling. We agree with this in the Atlas - since the launch of our genetic test it includes a free consultation with a geneticist.
Official FDA approval is important for all companies that conduct genetic testing. The Food and Drug Administration has openly said that this is not an isolated solution. A similar scheme for obtaining permission can be used by other companies that make genetic tests for users.
Source: https://habr.com/ru/post/403079/
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