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Cancer Genetics Risk Assessment and Counseling (PDQ®): Genetics - Health Professional Information [NCI] - The Option of Genetic Testing

Table 1. Clinical Utility of Genetic/Genomic Testsa continued...

The U.S. Department of Health and Human Services Secretary's Advisory Committee on Genetics, Health, and Society has published a detailed report regarding the adequacy and transparency of the current oversight system for genetic testing in the United States. The Committee identified gaps in the following areas:

  • Regulations governing clinical laboratory quality.
  • Oversight of the clinical validity of genetic tests.
  • The number and identification of laboratories performing genetic tests and the specific genetic tests being performed.
  • Level of current knowledge about the clinical usefulness of genetic tests.
  • Educational preparation in genetics of health providers, the public health community, patients, and consumers.

Direct-to-Consumer (DTC) Marketing of Genetic Tests

Over the last decade there has been a marked increase in companies advertising or providing genetic services directly to the consumer.[15,16,17] Accordingly, it is inevitable that an increasing number of patients will approach physicians and genetic counselors armed with information or genetic test results from DTC companies. In the next sections, information is provided about: (1) trends in DTC marketing of genetic tests; (2) concerns about DTC marketing of genetic tests; and (3) research examining the impact of DTC marketing of genetic tests.

Trends in DTC marketing of genetic tests

In 2002, a search of Internet-based studies found 14 genetic testing companies advertising adult health-related susceptibility testing, with only three companies actually offering testing directly to the public.[15,16] A 2005 and 2006 study identified 24 Internet-based companies providing DTC testing.[17] The companies surveyed offered diverse types of testing, including diagnostic tests for single high-penetrance diseases, such as Huntington disease; risk assessment tests for polygenic diseases, such as breast cancer and Alzheimer disease; and testing for many low penetrance genes that may have ramifications for health or well being, such as nutrigenomic or nutrigenetic tests or cardiovascular profiles. About one-quarter (24%) offered diagnostic and risk assessment tests; 21% offered all genetic tests; 21% offered enhancement tests only; 17% offered risk assessment and enhancement tests; 13% offered diagnostic tests only; and one company (4%) offered risk assessment tests only. The investigators for this study defined enhancement test as a test for one or more low-penetrance genes for the purpose of providing information on general aspects of health, nutrition, and/or treatment regimens, such as nutrigenetic or pharmacogenetic tests and cardiovascular health profiles. This study also examined the content of the Internet information and found that companies offering diagnostic and risk assessment tests were much more likely to indicate that a physician associated with the company would be involved in interpreting the tests than companies offering enhancement testing. Of these companies, eight did not require a physician to be involved in ordering tests or interpreting the results.[17] More than 75% of the 24 companies stated that they recommended or provided phone-based genetic counseling services. When genetic counseling was offered by the company, there was no information provided about the qualifications of the counselors and the scope of the information and counseling provided.

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