Diagnostics Reform and Harmonization of Clinical Laboratory Testing.

Developments in diagnostics reform legislation in the United States are occurring at a rapid pace. The framework for future regulatory oversight of clinical laboratory testing is currently under intensive debate among stakeholders that represent patients, practitioners, laboratories, diagnostic manufacturers, and regulators. The importance of clinical laboratory test standardization is a key component of any plan for regulatory reform. A laboratory-developed test is performed in a specific laboratory setting, often led by clinical laboratory professionals who possess specific expertise for developing and running the test to fill a clinical need. A test commercially marketed as an in vitro diagnostic kit is designed to operate across a spectrum of laboratory settings in laboratories with a range of expertise. Both types of tests are stringently regulated, laboratory-developed tests by the Clinical Laboratory Improvement Amendments and in vitro diagnostic kits by the US Food and Drug Administration. Interlaboratory comparisons of laboratory-developed tests have been published, demonstrating highly reproducible results. Comparisons of laboratory-developed tests with in vitro diagnostic kits have also found high concordance. Several important clinical laboratory test standardization projects are currently under way. The US Food and Drug Administration has acknowledged the need for such standardization. In its most recent draft guidance, the agency requested input from the scientific community as to actions that can be taken to facilitate standardization.