Regulating Laboratory-Developed Tests

The U.S. diagnostic market has long been divided into two major regulatory branches. In vitro diagnostic (IVD) kits that are sold by manufacturers to laboratories are regulated by the FDA. Tests developed by a laboratory and offered as a diagnostic service by that laboratory are regulated at the federal level by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA). This regulatory dichotomy appears to be ending.