Federal Neglect: Regulation of Genetic Testing; Government Needs to Ensure That Genetic Tests Provide Useful Medical Information and That the Test Results Are Reliable (Cover Story‪)‬

U.S. consumers generally take for granted that the government assesses the safety and effectiveness of drugs and other medical products before they are made available commercially. But for genetic tests, this generally is not the case. At the same time, the number and type of genetic tests continue to increase, and tests for more than 900 genetic diseases are now available clinically. Genetic testing is playing a growing role in health care delivery and is providing information that can be the basis for profound life decisions, such as whether to undergo prophylactic mastectomy, terminate a pregnancy, or take a particular drug or dosage of a drug. Current gaps in the oversight of genetic tests, and of the laboratories that offer them, thus represent a real threat to public health. Currently, the government exercises only limited oversight of the analytic validity of genetic tests (whether they accurately identify a particular mutation) and virtually no oversight of the clinical validity of genetic tests (whether they provide information relevant to health and disease in a patient). To the extent that oversight exists, it is distributed among several agencies, with little interagency coordination. As a result, no clear regulatory mechanism exists to guide the transition of tests from research to clinical practice, or to ensure that tests offered to patients are analytically or clinically valid. In order to protect consumers, and to help advance the potential benefits offered by genetic testing, government action is urgently needed.