• Andrea Ferreira-Gonzalez, Rajyasree Emmadi, Stephen P Day, Robert F Klees, Jennifer R Leib, Elaine Lyon, Jan A Nowak, Victoria M Pratt, Mary S Williams, and Roger D Klein.
• The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Division of Molecular Diagnostics, Department of Pathology, Virginia Commonwealth University, Richmond, Virginia. Electronic address: aferreira-gonzalez@mcvh-vcu.edu.
• J Mol Diagn. 2014 Jan 1; 16 (1): 3-6.

AbstractSince 2006, the US Food and Drug Administration, Congress, and other policymakers have explored the appropriate way to guarantee the clinical and analytical validity of laboratory-developed tests. In the past, the Association for Molecular Pathology has publicly urged the Food and Drug Administration to exercise caution in implementing regulatory changes that could potentially hinder innovation or interfere with the practice of medicine. In 2012, the Association for Molecular Pathology Professional Relations Committee chose to develop this paper with the goal of outlining the best methods for ensuring appropriate oversight and validation of molecular diagnostic procedures. At the conclusion of this process, the workgroup reaffirmed the Association's previous position that the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments program can provide the appropriate level of oversight for the vast majority of diagnostic tests. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

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