Weekly Trend: Genetic Testing Market Growing, Even After 23andMe Ban
It’s a new year, which means loads of offers pouring into inboxes from services we thought we’d unsubscribed from years ago. One that may catch your eye: a certain service that promises to map your genes—all for the sum of about $70. All you do is swab your cheek and your saliva reveals fascinating information about your ancestors.
It’s always tempting to seek information about ourselves, and thanks to the ease of shipping off your spit, DNA analysis is now a convenient thing to do. But is knowing your detailed genetic information an innocuous pursuit? The Food and Drug Administration still doesn’t think so.
23andMe, the one-time startup from Mountain View, Calif., that revolutionized the world of personal genome tests received a directive from the FDA in November of 2013: The company was no longer allowed to share analyzed health information with customers who purchased kits.
According to a piece in Nature, the reason for the injunction was that the information given about a customer’s health approximated a medical device; therefore, “Serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.”
Although customers willingly paid for the service, which included updates to the interpreted information provided by 23andMe, the FDA barred the dispersal of this information under the Federal Food, Drug, and Cosmetic Act.
However, the company recently announced that they will be providing the full suite of DNA analysis plus genetic interpretation in the United Kingdom. The Guardian reports that 23andMe’s genetic testing is not new in the country: The National Health Service has been working on a genome project of 100,000 people to better understand the mechanisms of diseases such as cancer. The draw in allowing 23andMe is more along the lines of making it more alluring to want to find out more about your genes in the first place.
Even if there are concerns about the proper use of the information, the allure of knowing more about oneself is undeniable. There is also the fact that services like 23andme, among many other competitors in the market, offer the possibility of connecting with blood relatives, if you’re adopted, and understanding a part of yourself that would otherwise be impossible to research. This emotional, personal connection—even if it can sometimes be devastating, in the event of illness or unraveled family secrets—ensures the lasting success of genetic testing.
The thirst for this information shows no signs of slowing down: From the National Geographic Genographic kit to Family Tree DNA, the proliferation of direct-to-consumer genetic testing shows that the market is only growing.
Currently in the United States, 23andMe continues to offer their kits and a raw, unanalyzed version of consumers’ genetic data. In the wake of the FDA decision, VentureBeat covered both opinions on the issue. On one side, the issue is presented as a personal right to know versus the danger of releasing information to a person who does not have the medical knowledge or training necessary to understand information that has the potential of being incomplete, since the testing cannot account for a full suite of genetic variants, according to Nature.
In the meantime, the team behind 23andMe is actively trying to reverse the ban, as well as using their technological expertise to shed more light on the human genome. Thanks to a grant from the National Institutes of Health—a government agency not connected to the FDA—23andMe will focus on disease variants in order to refine the information that it can provide to its customers. The findings will be published in peer-reviewed journals as well.