For the most part, genetic testing in the United States has developed successfully, providing options for avoiding, preventing, and treating inherited disorders. However, there are some problems and we should anticipate more. There is no assurance that all laboratories performing genetic tests for clinical purposes will meet high standards.
Problems occur concerning laboratory quality.
In the future, it is likely that a greater burden for making genetic testing decisions will fall on providers who have had little formal training in genetics or experience in considering the implications of predictive genetic tests. So far, except for neonatal and prenatal screening and diagnosis, the volume of testing has not been great and much testing has been performed in genetic centers or in consultation with highly trained geneticists and genetic counselors. In the next few years, though, the volume of genetic testing is likely to expand rapidly while the number of genetic specialists will remain essentially unchanged. In the past few years, professional societies have felt impelled to express concern publicly when a number of predictive tests were introduced with insufficient evidence of safety and effectiveness. Although formal comparisons have not been made, there is little evidence that the problems encountered in the development and delivery of genetic testing technologies have been more frequent or severe than for other medical technologies.