Genetic testing has overcome the barrier

FDA approves 23andMe tests for predisposition to diseases

Julia Korowski, XX2 century

US Food and Drug Administration (FDA) allowed biotech company 23andMe to trade genetic tests for predisposition to 10 diseases, including celiac disease, Parkinson's disease and Alzheimer's. The company announced that it will launch a new service in the coming months.

Inside the kit is a test tube for collecting saliva with a special nozzle.

23andMe offers its clients to undergo a genetic test at home without the participation of doctors. To do this, you need to buy a saliva collection kit, register by entering a unique test tube number and send the biological material back. The laboratory performs genotyping, 23andMe analyzes the data and posts it on its website (only the owner can view the report).

Initially, 23andMe, among other things, did tests for individual predisposition to many diseases. But in 2008, the FDA notified the company that it considers its kits as "medical devices", which means they can only be sold with the permission of the government. In 2013, the FDA banned the sale of individual genetic tests because the company did not provide evidence that they give accurate results. Management representatives were concerned that people would perceive the information on the site as absolutely reliable and would be guided by them when making important decisions with serious health consequences. The company had to focus on other services – determining the origin, searching for "genetic relatives" and so on.

Two years later, 23andMe was allowed to conduct tests that show the likelihood of developing certain diseases in children. But clients still could not assess the risks to their own health. And now this restriction has finally been lifted, however, so far only for 10 diseases. Tests for predisposition to Parkinson's and Alzheimer's diseases, as well as thrombophilia, will begin in April. "This is a watershed moment for both us and the FDA," comments 23andMe spokesperson Kathy Hibbs. "We are all very tired and very happy." However, it is worth remembering that the test results and the diagnosis are not the same thing: not only genetic predisposition, but also lifestyle and other factors affect the development of the disease.

Hank Greely, a bioethicist at Stanford University, fears that consumers will not be able to adequately perceive the information provided by the service without consulting a doctor or a geneticist. "I am not a big fan of the idea that it is necessary to remove the mediator, given the fact that the mediator is a qualified specialist, and most of the country's population knows little about health," he says. Nevertheless, the FDA's decision pleased the scientist, because biotech companies will have no reason to look for loopholes in the legislation. Of course, the FDA had questions not only to 23andMe, the regulator notified more than two dozen companies about the need to obtain permission. "This suggests that, working with the FDA, it is possible to move forward," Greeley explains the meaning of the new permit. "Silicon Valley has a neurosis about the FDA, and it's not good for the cause, especially in the field of healthcare, where human lives are at stake."

Portal "Eternal youth" http://vechnayamolodost.ru  10.04.2017