Revisiting oversight and regulation of molecular-based laboratory-developed tests: a position statement of the Association for Molecular Pathology.

Autor:	Ferreira-Gonzalez A; 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., Emmadi R; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Department of Pathology, University of Illinois Hospital & Health Sciences System, Chicago, Illinois., Day SP; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Hologic Inc., Madison, Wisconsin., Klees RF; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Wadsworth Center, New York State Department of Health, Albany, New York., Leib JR; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Cavarocchi-Ruscio-Dennis Associates, LLC, Washington, District of Columbia., Lyon E; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Department of Pathology, University of Utah School of Medicine, and ARUP Laboratories Salt Lake City, Utah., Nowak JA; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Department of Pathology and Laboratory Medicine, NorthShore University Health System, Chicago, Illinois., Pratt VM; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana., Williams MS; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Association for Molecular Pathology, Bethesda, Maryland., Klein RD; The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Department of Molecular Pathology, Cleveland Clinic Foundation, Cleveland, Ohio.
Jazyk:	angličtina
Zdroj:	The Journal of molecular diagnostics : JMD [J Mol Diagn] 2014 Jan; Vol. 16 (1), pp. 3-6.
DOI:	10.1016/j.jmoldx.2013.10.003
Abstrakt:	Since 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.)
Databáze:	MEDLINE
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