The U.S. Food and Drug Administration Friday approved 23andMe to market their health test for those who want to know if they have predisposed genes for 10 types of diseases, such as Parkinson’s or Alzheimer’s.
23andMe’s Personal Genome Service Genetic Health Risk (GHR) test, the first direct-to-consumer (DTC) test to gain FDA approval, provides information of a person’s genetic predisposition to the following 10 diseases:
- Parkinson’s disease, a nervous system disorder impacting movement;
- Late-onset Alzheimer’s disease, a progressive brain disorder that destroys memory and thinking skills;
- Celiac disease, a disorder resulting in the inability to digest gluten;
- Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease;
- Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements;
- Factor XI deficiency, a blood clotting disorder;
- Gaucher disease type 1, an organ and tissue disorder;
- Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition;
- Hereditary hemochromatosis, an iron overload disorder; and
- Hereditary thrombophilia, a blood clot disorder.
The FDA blocked 23andMe, a company invested by Google, from providing health information derived from personal genome testing in November 2013. In October 2015, however, the FDA opened up regulations to allow the company to provide gene information to those who could carry or pass on rare genetic diseases.
Now, with FDA approval, consumers can now purchase the GHR test and send saliva samples to the company, which will be tested for more than 500,000 genetic variants.
|Source: 23andMe homepage|
“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”
The GHR tests can provide genetic risk information to those who use it, but they cannot determine the overall risk of developing the disease due to various environmental and lifestyle factors that may contribute to disease development.
The GHR tests were authorized based on data from peer-reviewed, scientific literature that showed the correlation between specific genetic variants and the 10 diseases. The FDA also reviewed studies which found 23andMe GHR tests do correctly and consistently identify variants associated with the 10 indicated conditions or diseases from a saliva sample.
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