DNA testing company 23andMe — best known for analyzing saliva to determine your ancestry — has received FDA approval to sell kits that also test for 10 diseases, including Parkinson’s and Alzheimer’s.
This is the first time the FDA has approved an at-home, direct-to-consumer genetic testing product according to The New York Times — a shift from its 2013 moratorium on disease tests sold by the company.
So to recap: Now anyone can purchase a $199 Ancestry and Health test from 23andMe, spit in a vial, mail it in and then find out if they have ancestors from sub-Saharan Africa and whether they are genetically predisposed to conditions like celiac disease, blood clotting disorders and a lung and liver disease called Alpha-1 antitrypsin deficiency.
Genetic tests like these are typically only offered in professional medical settings, so what do you need to know about this new option?
This is not a diagnosis
Even when you get genetic testing under the guidance of medical professionals, the results are never clear-cut. Just because someone has a genetic marker for a certain condition doesn’t mean that they will develop it over time. It also doesn’t take environmental factors into consideration — just genes.
These tests are exactly that: tests, not formal diagnoses.
The FDA’s initial reasoning behind not permitting 23andMe for offering direct-to-consumer tests for diseases was that people might suffer undue mental anguish or make major — or even minor — medical decisions that may be unnecessary or even harmful.
When genetic tests are done in doctors’ offices, the patient has access to the doctor, who delivers the results, and frequently, a counselor specifically trained in dealing with the implications of genetic testing. Of course, someone who uses the at-home testing kit could also seek out professional counseling to discuss their results, but there is no guarantee that will happen.
How much is your personal information worth?
The value of your personal information — and keeping it private — is something you should seriously consider before using 23andMe’s new disease testing kit.
“Consumers may not be aware that 23andMe sells their DNA profiles and other personal information to companies who use the data for targeted advertising,” Dr. Celia B. Fisher, director of the Center for Ethics Education at Fordham University told SheKnows.
Fisher explained that offering the test at the $199 price point doesn’t actually cover the cost of the DNA testing. 23andMe makes up for that loss with profits gained from selling their consumers’ information.
“The personal information may also be sold to health insurers and employers with economic consequences for the consumer,” she added. “The true use of the data is not clear to consumers who are deprived of making an informed decision about its use.”
Knowledge is power?
There is a difference between being fully informed about your medical diagnoses and treatment and having access to information that may not accomplish anything aside from increasing your anxiety.
But Dr. Robert Green, a genetics professor at Harvard Medical School told The New York Times that most people who seek information about their genetic makeup are able to handle the results, and those who purchase the tests understand the risks.
“We’re moving as a society toward empowering people with health-related information and this is, I think, a welcome step along that way,” he told NBC News.
Along the same lines, Kathy Hibbs, chief legal officer at 23andMe told NBC News that after conducting “user comprehension” studies, the company was confident that consumers would be able to use the tests appropriately and seek professional guidance when necessary.
The FDA has indicated that the test will recommend that users “speak with a healthcare professional, genetic counselor, or equivalent professional before getting the results of the test.
Great idea, but definitely outside the $199 cost of the test, potentially excluding many of the consumers who opted for at-home testing over going to a clinic.
The bottom line is that if you decide to get the disease testing kit from 23andMe, don’t expect a firm diagnosis and talk to a professional about the results if you are able.