FDA vs. 23andMe
Google-backed company banned from genotyping people
<url>The U.S. Food and Drug Administration (FDA) has ordered 23andMe to stop selling genetic tests.
The reason was the company's statements, which allow us to consider these tests as a diagnostic product, for the release of which it did not have the appropriate license. Details are provided in the official letter of the FDA to the head of 23andMe Ann Wozicki.
The FDA's claims are caused by the fact that on the company's official website, as of November 6, statements were submitted that the proposed home-based tests could provide information "about 245 diseases and conditions", "susceptibility to drugs" and play the role of "the first stage of prevention". According to Albert Guterres, the head of the Center for Diagnostic Methods and Radiological Health, who signed the letter, all this gives the impression of a diagnostic technique that should be appropriately licensed.
The letter obliges to stop selling home-made tests until they pass FDA licensing. The Department has been investigating similar proposals from different companies for several years, and has been in long correspondence with 23andMe: the ban is motivated, among other things, by non-compliance with the regulations put forward in July and September 2012. Then the company was obliged to show that their test gives results no less reliable than FDA-approved methods.
As an example of the possible danger of non-certified tests, Guterrez indicates false positive results when assessing the risk of cancer. Patients with a high risk of ovarian or breast cancer often go for preventive organ removal and they may be prescribed potent drugs when benign neoplasms are detected. Both operations and additional chemotherapy increase the risk of complications with a possible fatal outcome, so the FDA considers it unjustified to use untested methods to assess the likelihood of cancer tumors.
The company 23andMe started its work in 2007. It provides genotyping services, that is, the determination of genetic characteristics for everyone. The company is not engaged in genome sequencing, but determines the presence of certain single-nucleotide features (polymorphisms, SNPs) in it using DNA microchips. The presence of certain SNPs may (or may not) be associated with an increased risk of developing many diseases — large-scale studies are required to establish the reliability of this relationship. In addition to medical applications, genotyping is also used to establish kinship and origin.
23andMe was founded with the financial support of Google. The head of the company is Ann Vozhitsky, the wife of Google creator Sergey Brin. Brin himself used the 23andMe service to analyze his DNA and found genetic features that increase the risk of Parkinson's disease, which was found in his mother, Evgenia Brin.
Portal "Eternal youth" http://vechnayamolodost.ru26.11.2013