Diagnostics Reform and Harmonization of Clinical Laboratory Testing

Publication date: Available online 8 May 2019Source: The Journal of Molecular DiagnosticsAuthor(s): Jeff Schreier, Robert Feeney, Peter KeelingAbstractDevelopments 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, providers, 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, by the Clinical Laboratory Improvement Amendments or by the US Food and Drug Administration, respectively. 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 shown high concordance. Several important clinical laboratory test standardization projects are currently under way. The US Food and Drug Administration has acknowledged the ...
Source: The Journal of Molecular Diagnostics - Category: Pathology Source Type: research