The US regulator allowed 23andMe to conduct a genetic test for Bloom syndrome directly to the consumer
The American regulator allowed 23andMe to conduct genetic testing for Bloom syndrome directly for private clients , with whom the company could not work since 2013 due to the ban of the authorities. From its inception in 2006 to 2014, the company conducted an analysis of susceptibility to diseases for more than seven hundred thousand people.
The structure of the complex of helicase syndrome Bloom (BLM) with DNA.
Founded in 2006, 23andMe is a private biotechnology company from Mountain View, providing customers with information about their susceptibility to diseases after genetic analysis, and also offering to learn about relatives. By September 2012, the service diagnosed one hundred eighteen types of genetic diseases. At the moment, the service database contains eight hundred and fifty thousand DNA records. Google has invested in the company - 3.9 million dollars, a consortium of investors led by Yuri Milner - 50 million.
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In 2008, the health departments of New York and then California sent companies to genetic companies, including 23andMe, a notice stating that they could not conduct genetic analysis on individuals until they were certified to become a clinical laboratory. In 2013, the Food and Drug Administration of the United States issued an order to suspend the sale of individual genetic tests. February 19, 2015 the same regulator allowed the company to conduct such tests without the participation of intermediaries in the form of doctors and clinics, but so far only for one disease - Bloom syndrome.
To obtain this permission, the company proved the ability of the average person to properly collect saliva for the test and to understand the meaning of the results, as well as his own ability to determine the presence of Bloom syndrome.
Bloom syndrome is a rare autosomal recessive disorder. It is characterized by low growth and predisposition to oncology, a skin rash on contact with sunlight, a high voice, moderate immunodeficiency and a number of other symptoms.
The structure of the complex of helicase syndrome Bloom (BLM) with DNA.
Founded in 2006, 23andMe is a private biotechnology company from Mountain View, providing customers with information about their susceptibility to diseases after genetic analysis, and also offering to learn about relatives. By September 2012, the service diagnosed one hundred eighteen types of genetic diseases. At the moment, the service database contains eight hundred and fifty thousand DNA records. Google has invested in the company - 3.9 million dollars, a consortium of investors led by Yuri Milner - 50 million.
')
In 2008, the health departments of New York and then California sent companies to genetic companies, including 23andMe, a notice stating that they could not conduct genetic analysis on individuals until they were certified to become a clinical laboratory. In 2013, the Food and Drug Administration of the United States issued an order to suspend the sale of individual genetic tests. February 19, 2015 the same regulator allowed the company to conduct such tests without the participation of intermediaries in the form of doctors and clinics, but so far only for one disease - Bloom syndrome.
To obtain this permission, the company proved the ability of the average person to properly collect saliva for the test and to understand the meaning of the results, as well as his own ability to determine the presence of Bloom syndrome.
Bloom syndrome is a rare autosomal recessive disorder. It is characterized by low growth and predisposition to oncology, a skin rash on contact with sunlight, a high voice, moderate immunodeficiency and a number of other symptoms.
Source: https://habr.com/ru/post/366317/
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