23andMe vs the FDA

For $99, a customer can spit into a tube and receive a detailed report on their ancestry and inherited risk factors for diseases such as diabetes, Alzheimer’s and Parkinson’s. 23andMe is a firm that provides such personal genetic testing. There are many benefits of ordering a test, such as knowing which medical conditions one is more likely to develop and being able to take preventative measures against the diseases that one has an increased likelihood of developing. The test can also reveal any adverse reactions one may have to certain drugs, help plan for a family by revealing carrier status for genetically inherited diseases and help one understand health risks. DNA tells us a lot about our health. This is the first time customers are able to have their DNA sequenced and receive a personal report. This is a major advancement in healthcare, as doctors can now help customers take personalized preventative measures and extend lifespans.

However, on Nov. 22, the Food and Drug Administration threw a wrench into the genetic information revolution underway in the U.S. Alberto Gutierrez, the head of the FDA's Office of In Vitro Diagnostics and Radiological Health, wrote a stern letter to 23andme, a genetic testing company, ordering it to stop marketing its service on the grounds that the service constitutes “medical advice,” which should only be released to the customer through a doctor. The FDA has concerns that people may misinterpret their results and overreact to prevent a condition for which the risk is actually negligible, potentially decreasing their health by taking inordinately extreme measures. For example, a woman with an increased risk for breast cancer may push her doctor to order a mastectomy that she may not necessarily need. The FDA holds that since people may make life-changing medical decisions based on the test results, the firm needs to verify that its data is accurate.

The FDA’s letter aimed at halting 23andMe advertising is not completely unwarranted, though. There are some requests from the FDA that the company did not follow up on, which prompted the letter. After the firm applied for FDA approval in 2012, the agency requested information on ensuring the accuracy of test results, which the company provided little of. In fact, there has been no communication between the two since May of this year. The company should pick up the ball and provide the information the FDA requested instead of ignoring the letter and continuing to market their $99 personal testing service. Though the company has until Dec. 13to respond, all attempts should be made to resolve the dispute with the FDA. 23andMe is the largest of the genome test providers and is therefore a crucial player in the personal genetic-testing phenomenon that has the ability to revolutionize the medical field. The genetic data collected from the 400,000 customers so far create a rich source of medical information for important research. As more people’s genetic information is added to the database, research and advancement in medical biotechnology can progress even further. But the FDA’s disapproval could halt this groundbreaking revolution in personal genomics.

While there is merit to the FDA’s claim that unnecessary medical procedures could be made from test results, founder and CEO Anne Wojcicki maintains that people have the right to know their own medical information. Preventing people from being able to access their genetic information takes away their ability to take potentially life-saving measures to protect themselves against the diseases they are at increased risk for. If the agency is required to verify genetic markers as precursors for disease, this may mean the end of direct company-to-customer flow of genetic information. While there is no way for the company to be able to ensure 100 percent accuracy for results, perhaps a rule could be put into place to let people access their results through a doctor to help them interpret the results and make informed medical decisions. Such a solution seems to be to the benefit of everyone involved.

College students like us should be aware of the options modern biotechnology has provided for us to care for our health. Personal genomic testing is very likely to become a staple in healthcare in the future, in which everyone gets their DNA analyzed to know the conditions they are prone to so they can make better lifestyle decisions. It is the government’s role to regulate new technology and promote the welfare of the people, but this is a revolution for medicine, biotechnology and personal genomics, and it is not worth halting a revolution because of a simple lack of communication between the company and the FDA. There is a great deal of information in our DNA, and there is the technology to know it. All that stands between us and enlightenment is a petty dispute between health-service providers and health-service regulators. They should take whatever measures necessary to end this spat if they are both truly committed to the common goal of promoting optimal health in the U.S.

Katherine Zhao is a freshman from East Brunswick, N.J. She can be reached at kz2@princeton.edu.