Most gene tests are offered as clinical laboratory services (rather than self contained "kits"), and while the U.S. Food and Drug Administration (FDA) has the authority to regulate such services, it has chosen not to because of a lack of resources. Although the quality of a laboratory to perform a test accurately is regulated under the Clinical Laboratory Improvement Amendments of 1988, no regulations exist that require evidence of a particular gene test's clinical validity (the probability that a person who tests positive will actually develop the disease) or it's utility (the potential for preventing or delaying the development of the disease in a person with a positive test). People who are educated in these medical uncertainties are less likely to choose gene testing when they are weighing their benefits against the possibilities of discrimination by insurers, employers, schools, and others.
Some companies have exaggerated both the validity and clinical utility of current gene tests in their eagerness to market these first commercial products of the "new genetics." Although most current gene tests are used to diagnose or predict a risk for developing rare diseases, testing for susceptibility to more common diseases --like heart disease and diabetes-- is the largest category of tests under commercial development. We can expect that aggressive marketing (some have called it "genohyping") will increase with the widening spectrum of tests developed, and some may in fact be offered directly to the public, a situation already occurring in the United Kingdom.

The Secretary's Advisory Committee on Genetic Testing of the U.S. Department of Health and Human Services is presently exploring these and other medical, scientific, ethical, legal, and social issues raised by the development and use of genetic tests. The committee has also sought public perspectives on these issues as it prepares its recommendations, which are due in the spring.