Proposed need for regulation of direct-to-consumer genetic testing

1. Direct to consumer genetic tests have increased in popularity due to technology, access, and affordable cost, and present both benefits and risks to the consumer. 

2. In order to mitigate risks and still offer consumers the potential advantages direct to consumer genetic tests may provide, this source study suggests the United States should impose stricter regulations to ensure patients’ safety. 

Evidence Rating Level: 4 (Below Average) 

Study Rundown: Direct to consumer (DTC) genetic tests have increased in popularity as access, low cost, and technology have allowed consumers to directly order test kits from the internet. Proponents of DTC testing have cited multiple benefits of DTC genetic testing, including the rights of individuals to access their own personal genetic information, which gives individuals the ability to make proactive, preventative lifestyle changes. Additionally, since consumers are not required to involve a physician, genetic test results do not become part of an individual’s medical record and a person’s genetic information remains private and secure, less vulnerable to employers or insurers.

Despite the potential benefits of DTC genetic testing, scholars have questioned whether DTC testing implicates problematic legal or ethical issues. Such arguments are highlighted in this Washington University report. DTC genetic tests may be prone to more mix-ups of individuals’ DNA and can technically be administered without direct consent from the individual whose DNA is being tested. Additionally, different DTC genetic testing companies have reached different conclusions in terms of assessing relative disease risks, which can confuse consumers and sheds light as to possible inaccuracies testing may have. Most problematic, individuals may potentially interpret results incorrectly and even make harmful medical decisions based on received results.

The United States federal government’s current regulation of DTC genetic testing has been done by the Food and Drug Administration along with other government committees and agencies, but no single regulatory agency has clear, explicit authority over the accuracy, design, or application of DTC genetic tests. Some suggest that United States can follow other countries’ regulatory approaches and require genetic counseling following testing results and standardized laboratory requirements for all DTC genetic testing companies to ensure consumers’ safety.

Click to read the article in Washington University Global Studies Law Review

Relevant Reading: Direct-to-Consumer Genetic testing: A Comprehensive View

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