Genetics testing has become incredibly popular and is a fast-growing industry. Companies like Ancestry and 23andMe offer people easy and relatively inexpensive at-home test kits, and a chance to discover who they are, genetically speaking.
While Ancestry has traditionally offered only a report on background and ethnicity, 23andMe took the process a step further by providing health reports. Based on your genetics, the company’s researchers could devise what diseases and health issues you are more susceptible to contract. However, the company pulled the reports when the FDA said that they lacked authorization.
Now after further consideration, the FDA has approved 23andMe to sell these health-related reports. The company has recently launched a marketing campaign appealing to those customers who were interested in genetics-based health reports, including health risks.
According to an article in The Los Angeles Times, The FDA said its review of 23andMe’s newly authorized tests determined that the company “provided sufficient data to show that the tests are accurate.” In other words, researchers can correctly identify genetic variants from customer DNA samples and provide “reproducible results.”
The approved reports include testing for specific conditions and diseases, including Alzheimer’s, Celiac disease, Parkinson’s disease, and Early-onset Primary Dystonia, a movement disorder that involves muscle contractions and tremors.
One concern the FDA mentioned in its approval was that people could draw conclusions about their health strictly from the results of genetic testing. In reality, people contract diseases based on various factors, including environment, health and eating habits, not just genetics.
23andMe reports provide “variants” associated with risk of certain diseases, but the mere instance of a variant doesn’t mean a person is certain to develop it. The absence of a variant doesn’t guarantee that someone won’t get the disease or condition, either.
The FDA wanted to make this clear. “It is important that people understand that genetic risk is just one piece of the bigger puzzle,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement.
Using a simple saliva test, 23andMe provides customers with a report confirming whether they have variants associated with certain conditions, and how likely they are to be susceptible to contracting certain diseases over time. Reports also include the individual’s ancestry, genetic traits, and whether a customer is a carrier for certain diseases. In some cases, the report will include the specific percentage describing lifetime risk.
The demand for certain reports will determine the future of this type of genetics testing. Do you want to know your risk for a disease like Alzheimer’s where there’s no cure? 23andMe is betting you will, in case there are steps you can take to decrease the risk.
