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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...

DTC genetic testing in children

One study identified 48 DTC companies and was able to contact 37 of them between December 2009 and April 2010 regarding participation in a survey about their company policies for testing children. Thirteen of the 37 companies participated in the survey, despite guarantees of confidentiality. Ten of 13 (77%) companies reported that they allowed genetic testing of minors; of these ten, nine reported receiving requests to test minors from parents or legal guardians. One company reported receiving a direct request from a minor to be tested. The investigators did not collect data on the types of tests the DTC companies provide; however, the implication is that most of the tests offered evaluate genetic susceptibility to adult-onset disorders.[18]

Concerns about marketing of DTC genetic tests

Several professional organizations have released position statements or recommendations cautioning against DTC advertising and provision of genetic tests. The main concerns that are expressed within these statements include the following:

  1. Patients may lack knowledge in key areas, such as the purpose and appropriateness of testing, accuracy, follow-up implications, clinical significance of results for themselves and other family members, or the reliability of the laboratory.
  2. The lack of required health care provider involvement and the lack of stated qualifications of the health care providers utilized by the companies themselves directs the onus on the patients to interpret complex findings or to take the initiative to seek other opinions.
  3. The lack of adequate regulatory oversight of laboratory tests documenting the analytic and clinical validity and clinical utility prior to test availability.[19]

In 2004, The American College of Medical Genetics Board of Directors asserted that genetic testing for susceptibility to disease are medical tests; therefore, these tests should be provided to the public through qualified health care professionals only. Given the complexities of genetic testing and counseling, telephone or Internet orders of home testing kits may be harmful because of the potential for inappropriate test use, misinterpretation of results, and lack of follow-up.[20] More recently, the American Society of Human Genetics (ASHG) [21] provided a policy statement on DTC genetic testing, citing the need for broader oversight of laboratory assessments by the FDA and Federal Trade Commission (FTC) in order to ensure reliable tests. The ASHG statement [21] recommended a series of standards in the area of transparency, provider education, and test and laboratory quality, and concluded that further research and federal oversight are needed in this rapidly changing field. In 2006, the FTC and Centers for Disease Control and Prevention issued a joint statement to consumers regarding the limitations of DTC genetic tests.

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