Genetic testing for breast and ovarian cancer susceptibility: evaluating direct-to-consumer marketing—Atlanta, Denver, Raleigh-Durham, and Seattle, 2003

Morbidity and Mortality Weekly Report, July 16, 2004

In the United States, regulatory oversight of genetic testing is limited, and no process exists for review of the accuracy and impact of advertising claims about validity and utility of genetic tests. However, translation of genomic discoveries to medical practice continues to yield new applications for diagnosis, promise for new disease treatments and preventions, and increased consumer interest and demand for genetic testing.

Public health agencies should provide information about genetic tests to educate consumers and providers and protect consumers by ensuring the safe and effective use of genetic tests. Collaboration among public health agencies, health-care providers, the clinical laboratory/biotechnology industry, and professional organizations will be required to develop a systematic approach for evidence-based assessment of the clinical validity and utility of genetic tests, identify gaps in knowledge, and to determine test efficacy, utilization, and access through postmakert surveillance. Such partnerships will be needed to support public health responses as genomics becomes more integrated into health promotion and disease prevention.