Last week, the Food and Drug Administration authorized personal genomics company 23andMe to sell genetic tests that could inform consumers about their risks of developing 10 different diseases, including Alzheimer’s and Parkinson’s.
These tests are the first direct-to-consumer tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions.
“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” Anne Wojcicki, 23andMe CEO and co-founder, said in a press release.
The company has been providing the newly FDA-approved genetic tests in Britain and Canada since 2014.
But before you send in your saliva sample and spend $199 on the home kit, here’s what you need to know:
What is 23andMe?
23andMe is a personal genomics company that helps individuals understand the human genome, and allows consumers to buy one of two personalized at-home genetic tests.
What’s the difference between the two services 23andMe offers?
Ancestry service: Tells you about your family history, how much you inherited from Neanderthals, how your DNA breaks out across 31 global populations and more. ($99)
Health + Ancestry service: Combines ancestry service and tells you what your 23 pairs of chromosomes say about your wellness, carrier status for traits and conditions ranging from genetic weight to balding to risk of Cystic Fibrosis and many others. ($199)
How does it work?
Both the Ancestry and Health + Ancestry services require consumers to submit a saliva sample using a saliva collection kit.
After ordering your service online, the collection kit will be delivered to you.
Once you register your saliva tube using the barcode included and submit your sample, just mail the kit back to the lab in the provided pre-paid package.
Your genetic reports will be emailed to you about six to eight weeks later.
What diseases can 23andMe tell me I’m at risk for?
The FDA now allows the company’s $199 service to assess genetic risks for the following 10 diseases or conditions:
- Parkinson’s disease
- Late-onset Alzheimer’s disease
- Celiac disease
- Alpha-1 antitrypsin deficiency
- Early-onset primary dystonia
- Factor XI deficiency
- Gaucher disease type 1
- Glucose-6-phosphate dehydrogenase deficiency
- Hereditary hemochromatosis
- Hereditary thrombophilia
So, will it tell me if I’ll develop one of the diseases mentioned above?
The results by no means guarantee a person will get the disease, experts say. It just scans your DNA for genetic mutations to find out if your chances of developing a certain condition or disease are higher than those of the average person.
“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,” James Beck, chief scientific officer of the Parkinson’s Foundation, told STAT.
Do I need a prescription to buy the health service?
No. The Health + Ancestry test is available directly to consumers. You do not need to see a physician or genetic counselor before purchasing the at-home test.
However — especially when there is no known cure for the disease — John Lehr, CEO of the Parkinson’s Foundation, advises individuals interested in genetic testing seek guidance from both doctors and counselors to “understand what the process may mean for them and their families.”
What’s the difference between this new FDA-approved test and 23andMe’s previous 2015 test?
According to the New York Times, in 2015, the FDA allowed 23andMe to reveal to consumers if they had a copy of a mutated gene for a disease such as cystic fibrosis that wouldn’t affect them personally, but could affect their future children.
Because you need two copies of this specific mutated gene to get cystic fibrosis, if you and your partner both have the mutation, each child you have has a 25 percent chance of inheriting the gene from each parent, which would give the child the disease.
“The difference between then and now is that we now have authorization to tell you about your personal risk,” Wojcicki said.
The new tests will begin to roll out in April and will be available to new customers immediately, the company announced. Current customers will be notified of test availability.