The U.S. Food and Drugs Administration approved Thursday the sale of 23andMe’s personal genetic tests for ten diseases, becoming into the first direct-to-consumer DNA test to be approved in the United States.
After a few changes made by the FDA, it decided to approve 23andMe product for diseases including Alzheimer’s, Parkinson and Celiac Disease. According to the FDA, this test helps people by measuring their genetic risk, but it is not a diagnosis. They decided to approve it because they estimate that it would help people to make a decision about their lifestyle and choices.
“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” said Anne Wojcicki, the CEO, and co-founder of 23andMe, in a company press release.
23andMe’s test will assess genetic risks for ten diseases
The FDA previously suspended the sale of the company’s personal genetic testing kits in 2013 since they were marketing the product without FDA’s consent. 23andMe decided to work by FDA’s terms. The FDA conducted several studies, and it decided to grant the company the approval to market the personal DNA tests in the U.S. on Thursday. However, this tests will only assess the genetic risks of the following ten diseases:
Parkinson’s disease, celiac disease, late-onset Alzheimer’s disease, alpha-1, early-onset primary dystonia, factor XI deficiency, gaucher disease type 1, glucose-6-phosphate dehydrogenase deficiency, hereditary hemochromatosis and hereditary thrombophilia.
It is highly important for people to understand that the genetic risks are not determinant. It doesn’t mean people are going to end up developing the disease, according to Jeffrey Shuren, who is the director of the FDA’s Center for Devices and Radiological Health. There are other risks factors, besides DNA, that have an important role in the development of a disease including lifestyle, diet, tobacco and drug abuse.
What does the test really say?
Customers need to take a saliva sample and send it by mail. Then they can check their results online. The test says if a person carries or lacks a DNA variant that according to specialists, is associated with a higher risk of a disease. The report will specify a percentage stating the disease risks. The tests don’t say if the person has a disease or if they will have it someday.
“It’s important for people to know that even if they have a mutation in the genes [associated with Parkinson’s that 23andMe will test for], by and large, they won’t get Parkinson’s disease,” said James Beck, chief scientific officer of the Parkinson’s Foundation.
23andMe reports that the tests results are more relevant for European descent, in the case of Alzheimer’s disease. As well, they are more accurate for European, Ashkenazi Jewish, and North African Berber descent in the case of Parkinson’s disease. And in the case of Factor XI Deficiency, the results are more relevant for people of Ashkenazi Jewish descent.
Direct-to-consumer testing takes away a pre-test conversation
Though this might be a great tool to know the genetic risks each individual has without having to go to the doctor, some specialists have shown concern about the effects this test might cause on people. Robert Green, a professor of medicine at Harvard Medical School, says that some people will prefer going to the doctor instead of having this saliva test still. However, he believes that both channels are legitimate, but people must keep in mind that managing this information is complicated.
Mary Freivogel, a certified genetic counselor and the president of the National Society of Genetic Counselors, says that consumers will “take the results and run” because they will accept it as the whole truth without consulting about it with their doctors. She says that people should speak with a genetic counselor before getting tested, but she thinks this test takes away pre-test conversation. She says that people might not be prepared to have that information, nor what they are going to do with it.
“Women learn they are pregnant using a test directly marketed to them and buy it off the shelf in a drugstore. In 10 years we will marvel that this is an ‘advance’ at all. Imagine pregnancy tests being only available through a doctor!,” said Sharon Terry, the CEO of the Genetic Alliance, which is a nonprofit organization that advocates for health care for people with genetic disorders.