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Markkula Center for Applied Ethics

Direct-to-Consumer Genetic Testing and the Vulnerable: Promoting Justice in Healthcare

Hand drawn Dna models.

Hand drawn Dna models.

Francis Lai ‘24

Francis Lai ’24 is a junior majoring in public health and a 2023-24 health care ethics intern at the Markkula Center for Applied Ethics. Views are his own.


In 2022, the direct-to-consumer genetic tests (DTC-GT) market surpassed 3 billion U.S. dollars. It is estimated 100 million individuals have completed a DTC-GT. In the fiscal year 2022, industry giant 23andMe reported 272 million dollars in revenue. Two major reasons for this growth are that DTC-GTs are easily accessible through major retailers such as Amazon and Walmart and do not require a medical professional to authorize the test. 

While the DTC-GT market has blossomed since the early 2000s, there is growing concern about appropriately regulating the process of at-home genetic tests. Historically, a key component of the patient-provider relationship in healthcare has involved discussing risks and implications of genetic test results with patients before and after testing. Unlike other genetic tests done in clinics or hospitals, the consumer independently initiates and completes a direct-to-consumer genetic test

Imagine you order a DTC-GT, submit the test, and a few weeks later the 23andMe website says you have a BRCA mutation conferring a predisposition to breast cancer. Wouldn’t you be stunned, afraid, and anxious? Wouldn’t you want an explanation from a qualified provider? Unfortunately, no DTC-GT company provides direct access to a qualified provider to discuss each test’s results. Rather, consumers of 23andMe rely on an explanation from an online portal where pop-up messages remind them about the limitations and risks of DTC-GT. 

While there are pre-produced videos and articles by certified counselors attempting to explain test results, this is not sufficient. In fact, 23andMe’s website advises consumers to “consult with a healthcare professional for help with interpreting and using genetic results.” Unfortunately, no major DTC-GT company goes beyond these words of advice to actually provide the counseling services it recommends. As the DTC-GT market grows, it is imperative to understand the potential for negative impacts on the most vulnerable consumers, specifically individuals concerned about their test results and historically marginalized communities.

Psychological Impacts & a Need for Counseling

DTC-GT companies are not legally required to provide direct access to a qualified provider to discuss each test’s results. Therefore, none of the major DTC-GT companies currently provide this direct access, likely because this would be expensive and reduce profit. Many individuals who take DTC-GT are generally healthy and are not concerned when receiving negative test results. However, it is clear that consumers who test positive for genetic risk factors are often alarmed about such results and would benefit from the support of a qualified professional. A study examining the psychological impact of DTC-GT results found that receiving a positive test result was associated with greater anxiety and stress. 

Furthermore, blog posts written by genetic counselors describe their experiences with DTC-GT consumers worried about their test results. They explain how these consumers clearly benefit from the presence of a qualified provider. Furthermore, these advocates argue that consumers are vulnerable to acute emotional distress from concerning or ambiguous test results. Among these advocates, the National Society of Genetic Counselors explains that DTC-GT companies should provide direct access to a qualified professional for all consumers. Previous studies show that pre and post-test genetic counseling is essential for lowering the stress of positive test results and reducing their misinterpretation. 

Consumers’ Best Interests

One ethical issue at stake is these companies are failing to sufficiently promote the beneficence of vulnerable consumers. Providing direct counseling would be the most effective method of promoting consumer well-being. But instead of providing these services, DTC-GT companies such as 23andMe display disclaimers in their web portals that explain that “these tests are not to be used as health information and to seek out a qualified professional if you have concerns.” But are these warnings truly effective in deterring consumers from worrying about their results or using the information to make lifestyle changes? 

The reality is that many patients choose DTC-GT because they are interested in their disease risks. In fact, 23andMe brags that it is the first DTC-GT that includes reports that meet FDA requirements for being scientifically and clinically valid. It is clear consumers purchase these tests advertised to them as effective to learn more about their health traits, and many use it to potentially make lifestyle changes. 

These disclaimers are an insufficient attempt by DTC-GT companies to promote their consumer’s well-being. Rather these disclaimers are merely a legal obligation, and the evidence is clear that this is failing the most vulnerable consumers.

Vulnerable Consumers are the Most Afflicted

The main ethical principle at stake here is justice, which explains that all people should get what is due to them. In the current state of DTC-GT, this principle is clearly violated. Individuals with concerning test results are not guaranteed support from a qualified professional to explain their test and results. Rather, access to follow-up care is determined by social determinants and the impact of structural barriers. 

Specifically, historically marginalized communities are less likely to seek the help of a qualified professional. People of color are significantly less likely to speak to a medical professional about an abnormal DTC-GT result. This is because of multiple barriers, including systemic barriers and historical mistrust of the U.S. health care system. Furthermore, individuals of lower economic classes may be hesitant to spend more money on a genetic counseling session. A single genetic counseling session without testing costs about $100, which may deter some consumers. Clearly, DTC-GT companies are not working towards a more just society in which individuals should receive what is due to them without discrimination or bias. Unfortunately, we live in a society where social determinants and structural barriers limit historically marginalized populations from accessing follow-up care and genetic counseling. DTC-GT companies are furthering these barriers by not facilitating direct access to a qualified genetics professional.

The question remains, how can we ensure that all of their consumers have access to a qualified professional to discuss results? Currently, 23andMe and other companies have no legal or business incentive to provide such service, leaving their most vulnerable consumers the most afflicted. 

In the future, our society needs to consider how disparities occur in the growing field of DTC-GT. DTC-GT benefits many, providing them with actionable information to be proactive about their health. However, individuals receiving positive results are the most affected by the lack of direct access to a qualified professional. Furthermore, historically marginalized communities are less likely to access a qualified professional and cannot benefit in the same way as others. DTC-GT companies must provide direct access to a qualified professional to discuss concerning results to ensure equal access for all. 


May 2, 2023

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