Benefits and risks of emerging genetic technologies: the need for regulation

Efforts to localize human genes to specific chromosomes and then to identify these genes and their role in specific diseases are increasing. These developments will expand the repertoire of genetic tests that are claimed to be predictive of future disease in the person being tested (pre-symptomatic tests) or in future offspring of those being tested (tests for reproductive options). In single-gene (mendelian) disorders, such tests may fail to detect all of the alleles capable of causing disease. In multifactorial disorders, positive results of tests for specific alleles will not always predict future disease because the other necessary factors may be absent. Policies are already in place to provide safe and effective clinical laboratory tests and interventions for subjects with positive test results, and to assure the quality of the laboratories performing such tests, but are not widely known or enforced for genetic tests.