July 06, 2007 - Despite increased attention to the potential of direct-to-consumer (DTC) genetic tests to mislead consumers or waste their money – including a Federal Trade Commission warning in July 2006 – 25 states and the District of Columbia permit DTC laboratory testing without restriction, according to a new survey by the Genetics and Public Policy Center. While the variety and complexity of genetic tests available DTC continues to grow, only 13 states prohibit DTC testing, while 12 permit it only for specified categories of tests, which tend to exclude genetic tests.
Consumers typically rely on health care providers for genetic testing; however, companies also have begun marketing directly to consumers. DTC testing allows consumers to order through the Internet, phone, or mail a broad range of health and non-health related tests directly from laboratories. Critics argue that by bypassing health care providers through DTC, consumers are more vulnerable to misleading or exaggerated claims about the benefits of genetic tests and may select incorrect or unnecessary tests and misinterpret test results. Others believe DTC testing may empower consumers if done appropriately, but raise concerns about the lack of federal oversight for genetic testing quality more broadly.
The Center compiled the data through surveys of state statutes and telephone interviews with state government officials. The chart details DTC testing laws for each state and the District of Columbia. Federal regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) leave the permissibility of the DTC test to the discretion of individual states. Although CLIA requires laboratories to have a "written or electronic request for patient testing from an authorized person" (42 C.F.R. § 1241(a)), states can define for themselves who is an "authorized person."
While laws in several states clearly addressed whether or not DTC laboratory testing was permitted, laws in other states were ambiguous or silent. Laws concerning DTC tests often appeared in different sections of state statutes, sometimes under professional regulation of the practice of medicine, sometimes under regulation of clinical laboratories. Laws also did not consider the various scenarios that have arisen as DTC has spread, such as using a physician employed by the DTC company itself to order testing as a means to circumvent practice of medicine restrictions. Additionally, even states that prohibit DTC may be stymied by the Internet-based nature of DTC testing, which facilitates cross-border sales and complicates enforcement of state laws. Ambiguous state laws, coupled with the fluid and dynamic nature of the DTC marketplace and weak federal oversight of genetic testing, raise concerns about whether safeguards are adequate to ensure consumers ordering tests DTC are receiving accurate and reliable genetic testing.
Read the chart of laws governing DTC tests in each state
Read the issue brief, "Direct-to-consumer genetic testing: empowering or endangering the public?"
Read the editorial, "Pink or blue? The need for regulation is black and white"
Read the issue brief, "Who regulates genetic tests?"
Read the feature article, "Senate Committee Examines Direct-to-Consumer Genetic Tests"
Read the article, "Oversight of US Genetic Testing Laboratories"
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