Judicature Genes and Justice
The Growing Impact of the New Genetics on the Courts
November-December 1999 Vol 83(3)
|Who's regulating gene tests?
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,
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.
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Denise K. Casey is a science writer, editor, and educator with the DOE Human Genome Program Human Genome Management Information System at Oak Ridge National Laboratory. She has written numerous articles for technical and lay readers on genetics and its applications and has served as a faculty member at judicial education seminars.
|The online presentation of this publication is a special feature of the Human Genome Project Information Web site.|