Over the past several years, at-home DNA tests have become commonplace. People gift popularized at-home tests––like 23andMe––to family members or purchase it for themselves to indulge in a curiosity about their genetic information. Eager people can learn about their heritage and other traits linked to their DNA, but are these tests as harmless as they seem? Where is your DNA data stored? Who has access to it? Are all the results and data given to the consumer accurate? The answers to these questions may be surprising and will have you think twice before purchasing an at-home DNA test.
One of the salient issues with the current system of at-home genetics testing is privacy. Who exactly has access to your DNA once you send it in for evaluation? Is it just the DNA test company itself? Unfortunately, that is so often not the case because many DNA testing companies are associated with big pharmaceutical companies. For instance, 23andMe and GlaxoSmithKline have a $300 million deal to research and develop new medicine. This may seem beneficial in theory, but as more companies gain access to a person’s genetic information, the more likely it is that this information can and will be used against the consumer. Additionally, once your DNA is submitted to a company with your consent, law enforcement has the right to request and access your genetic information through one of these companies––should it be deemed necessary in a legal context. Essentially, once you send in your small vial of saliva, a third party has the right to share your genetic information to other parties.
Furthermore, the accuracy of at-home DNA tests should remain under scrutiny. Consumer’s results, as harmless as they may seem, may be misleading. Many people gift these tests or decide to do them themselves to learn about their ancestry. Knowing you are 15% Lithuainian, 20% Hungarian, 5% Italian, and so on may seem interesting, and some of these results may actually be accurate. However, the source of such information is skewed, so ancestry results may not be as accurate for some as they may seem. Companies like 23andMe compare sequences of DNA in your sample to the compiled backlog of DNA sequences from all the other samples of people who have done the tests. In the beginning, they asked people from around the world to donate their DNA to start the sequence comparison. However, the vast majority of people that agree and fit the qualifications to participate in 23andMe research come from European descent. Hence, the at-home test results of caucasian people are more accurate than the results given to people of other racial backgrounds due to the lack of DNA to establish an accurate database for comparison. This presents a legal problem because companies will include broad statements claiming that all results are not 100% accurate. However, many unaware consumers fail to recognize when their data leans more inaccurately because the company purposely neglects the euro centricity of their product. Legally and contactually the test company has covered their bases with the consumer, but due to the scientific and complicated nature of DNA and DNA testing methods, the consumer often fails to realize the terms and conditions of their results.
The inaccuracy of data reaches far beyond ancestral information into potentially more harmful territory: health and medical information. 23andMe used to offer information about health such as predispositions to various diseases as part of their DNA analysis until 2013. The FDA then banned 23andMe from continuing to do so because the company had no reports of how their information accuracy was tested. People would receive information stating that they are 20% more likely to develop this kind of cancer or 30% more likely to develop heart disease. The potentially inaccurate figures and statistics incited unwarranted panic for many that received such information. So, what should people do with this information? In 2017, the FDA deemed that 23andMe had enough scientific accuracy to report health information about 10 select medical conditions. The FDA’s actions symbolized a better start in ensuring public safety with this product, but the company’s lack of legal responsibility–stated in the contract signed by the consumer–allows the product’s inaccurate results to mislead consumers. This presents a dilemma because the consumer still has no legal means for reparations based on falsely reported information, which is of serious concern, especially when related to a person’s health.
The nature of biolaw contributes to the reason why at-home DNA tests present themselves as problematic. Biolaw, a continuously developing field, often cannot keep up with the rapid development of technology, which includes cases that protect one’s rights to access an individual’s DNA. Unlike many other types of discrimination, genetic discrimination is not expressly defined or explained in anti-discrimination laws such as the Americans with Disabilities Act (ADA). As genetic technology advanced, the Genetic Information Nondiscrimination Act of 2008 (GINA) was written to protect people from insurance companies and employers from using genetic information as a method of discrimination. However, at-home DNA tests present a new challenge to these laws that are already unclear about access to DNA. Laws have still yet to thoroughly address at-home DNA tests, so until that happens, there will be a lack of clarity to the consumer of how and by whom their DNA can be accessed.
Both scientists and legal experts realize the lack of clarity in current genomic laws and the desperate need for a plan of action to progress these laws forward to provide people with the protections they need of their own DNA. Scientists and lawyers at the University of Minnesota and Vanderbilt University have completed a three-year long project called LawSeqSM, which aims to create a public database of the current genomic laws as well as propose a plan for the best way to move forward and progress these laws. For example, the LawSeqSM project held a symposium in 2018 that talked about informed consent, which refers to a patient’s ability to refuse or consent to treatment. Lawmakers and scientists are looking to make the processes and definitions of legal consent more specific and update them to apply to current scientific and medical practices. This project hopes to encourage more legal clarity so genomic research can be more effectively used in the future of medicine without crossing legal boundaries of genetic ownership. Although this project targets clinical uses of DNA to advance medical treatments and therapies, the legal clarity that will hopefully come from projects like this one will ultimately benefit the clarity of DNA ownership in all of its applications, including at-home DNA tests.
Due to the lack of clarity of genetic laws in the United States, at-home DNA tests present a variety of risk factors. When a consumer sends a sample of their DNA back to the company, a third-party owns their DNA, which the consumer may neither want nor be aware of. Until the FDA made regulations in 2013, at-home DNA tests could provide information about health, although not guaranteed accurate, it caused panic for many individuals. Members of both the science and legal communities have attempted to persuade politicians and policy makers to progress genomic law forward at a rapid pace. The amount of invaluable information that one tiny vile of saliva can give about a person should be looked past. Until clearer genetic law is created, it may be wise to skip a 23andMe test as your next gift for a friend, loved one, or even yourself.