Who does have regulatory oversight of genetic testing?
In the United States, genetic tests are subject to federal regulatory oversight through two mechanisms. The first mechanism is U.S. Food and Drug Administration (FDA) regulation of test kits sold to laboratories by commercial manufacturers as diagnostic devices. To date more than 50 tests have been cleared or approved by FDA. However, most genetic tests currently offered by laboratories in the U.S. do not involve the use of commercially available FDA reviewed kits. Instead, laboratories develop and offer tests as a clinical service; such tests are known as laboratory developed tests or LDTs. The FDA also regulates “analyte specific reagents,” component reagents that are used by laboratories as part of genetic LDTs.
