What should I know before proceeding with direct-to-consumer genetic testing?

There are many things to consider before ordering a direct-to-consumer genetic test. For example, it is important to understand the limitations of direct-to-consumer genetic testing and the potential privacy risks. This kind of genetic testing can also affect your ability to obtain certain types of insurance.

Before ordering a direct-to-consumer genetic test, look for detailed information on the company’s website that spells out the services the company provides, the company’s responsibilities, and your rights as a customer. This is often called the “terms of use” or “terms of service,” and it is a legally binding agreement between you and the company that provides the testing. If you have questions, you should contact the company directly to get more information.

Testing Limitations

Before you proceed with direct-to-consumer genetic testing, make sure you understand what the tests can and cannot tell you. Direct-to-consumer genetic testing generally cannot tell for certain whether or not you will develop a specific disease, as many common health problems are caused by a combination of genetic, environmental, and lifestyle factors.

Standards and guidelines may differ between direct-to-consumer genetic testing companies and companies that offer genetic testing through a healthcare provider. As such, results from direct-to-consumer genetic testing companies typically need to be confirmed by additional testing ordered through a healthcare provider before they can be considered diagnostic and used to make medical decisions.

Questions to consider about direct-to-consumer genetic testing companies may include:

• Are the tests regulated by the U.S. Food and Drug Administration (FDA)?
• Does the laboratory have a certification from the Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP), or the Association for the Advancement of Blood & Biotherapies (AABB)?
• Is the company clear about what a test can and cannot tell you?
• How many genetic variants are tested for each condition? Is it enough to make the results meaningful?
• Does the company discuss the need for additional testing to confirm results?
• What should you do if you have questions about your results?
• Does the company have experienced genetics professionals, such as medical geneticists and genetic counselors, on its staff?
• Is a consultation with a healthcare professional (such as a genetic counselor) included in the cost of testing?
• Will you be notified if future research changes or impacts your results?

Privacy Issues

Your DNA, like your fingerprint, is unique to you. However, people do share some DNA with their relatives, so information that you learn through a direct-to-consumer genetic test may also have implications for your family members. Because your genetic information is part of your personal and family health information, it is important to understand what direct-to-consumer genetic testing companies do with this data.

Questions to consider about the company’s privacy policies may include:

• How does the company safeguard your genetic data and other personal information?
• What happens if the database is hacked or otherwise compromised?
• What would happen to your sample and your genetic information if the company is sold or goes out of business?
• Can you delete your results and your genetic information from the company’s database?
• Does the company share or sell their customers’ genetic data to pharmaceutical or technology companies for research or other purposes?
• What is the company’s policy on sharing genetic data with law enforcement?
• Can you opt out if you do not want your genetic data shared, sold, or used for research?
• Can you agree to share your information but opt out later?
• Will you be notified in the future if the company changes its privacy policies?

Most direct-to-consumer genetic testing companies provide detailed information on their websites about their privacy and security practices. This information may be included in a “privacy policy,” “privacy statement,” or “privacy center.” Be sure to read, understand, and agree with this information before you start the testing process.

Insurance Issues

A federal law passed in 2008 called the Genetic Information Nondiscrimination Act (GINA) makes it illegal for employers and health insurance providers in the United States to use the results of a direct-to-consumer genetic test (or any other genetic test) to make decisions about a person's health insurance eligibility or coverage.

However, there are important limitations to these protections:

• GINA does not apply to companies with fewer than 15 employees.
• GINA protections do not apply to other forms of insurance, such as disability insurance, long-term care insurance, or life insurance. Companies that offer these types of insurance policies have the right to request the results of genetic testing when making decisions about eligibility, coverage, and rates, unless these requests are prohibited by state laws.

Consider the pros and cons of participating in direct-to-consumer genetic testing before starting the testing process.