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Federak Regulation of Genetic Testing

The growth in science and technology is incredible; the fact that a simple swab of a cheek can bring somebody a full genetic report is something that was unheard of decades ago. However, the simplicity of genetic testing is not always good. As it is currently unregulated by the federal government, genetic testing may introduce doubts of accuracy and safety. With such a discovery in our midst, at times it is difficult to distinguish whether genetic testing is an asset or a bane to society.

Direct-to-Consumer (DTC) genetic tests are tests that can first be obtained without a doctor’s permission or genetic counseling, which introduces risks of misinterpretation. Numerous DTC tests do not give a definitive answer as to whether a patient will or will not develop a condition, but rather provide only the patient’s probability of developing a disease. The interpretation of these results is thus highly nuanced, and must be clearly communicated and explained to the patient. Misinterpretation of test results may lead to unnecessary emotional stress and compulsive decisions.

Currently, the federal government exercises a limited oversight of the accuracy and relevance of genetic tests. The oversight that exists is distributed among various agencies with little to no coordinated regulation. As a result, there is no guarantee that test results are reliable. The lack of control over marketing claims has also resulted in false or misleading claims. Although the Federal Trade Commission (FTC) regulates the advertising of genetic tests, it depends on the U.S. Food and Drug Administrations (FDA) for appropriate claim parameters. Yet the FDA does not regulate most genetic tests, and most genetic tests developed by clinical laboratories do not require approval from FDA before they can be marketed. With consumers prone to misleading advertisements as well as lack of genetic counseling, there is bound to be major issues and complaints of misinformation and unfulfilled expectations.

Examples of false and misleading advertisements include those that fail to mention how breast cancer does not have an underlying hereditary cause. They may also exaggerate the benefits and downplay the possible risks or complications of genetic testing. In order to protect consumers and advance the benefits of genetic testing, more government action and regulation are needed.

Cooperation between the government and private businesses is crucial to a solid regulatory system that will minimize the occurrence of inaccurate and unreliable genetic tests. It is important that as further developments in technology continue to change and enhance genetic testing, federal regulations are made accordingly.