title: Revisiting oversight and regulation of molecular-based laboratory-developed tests: a position statement of the Association for Molecular Pathology.
abstract: 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.
authors: 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.
authors: Andrea
authors: A
authors: Ferreira-Gonzalez
authors: 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.
authors: Rajyasree
authors: R
authors: Emmadi
authors: The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Hologic Inc., Madison, Wisconsin.
authors: Stephen P
authors: SP
authors: Day
authors: 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.
authors: Robert F
authors: RF
authors: Klees
authors: 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.
authors: Jennifer R
authors: JR
authors: Leib
authors: 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.
authors: Elaine
authors: E
authors: Lyon
authors: 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.
authors: Jan A
authors: JA
authors: Nowak
authors: 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.
authors: Victoria M
authors: VM
authors: Pratt
authors: The LDT Working Group of the Association for Molecular Pathology (AMP) Professional Relations Committee, Bethesda, Maryland; Association for Molecular Pathology, Bethesda, Maryland.
authors: Mary S
authors: MS
authors: Williams
authors: 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.
authors: Roger D
authors: RD
authors: Klein
mesh_terms: D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009934:Organization and Administration / Q000592:standards; D012680:Sensitivity and Specificity