Revisiting oversight and regulation of molecular-based laboratory-developed tests: A position statement of the association for molecular pathology

Journal of Molecular Diagnostics

Volumn 16, Issue 1, 2014, Pages 3-6

  Ferreira Gonzalez, Andrea ^a,b   Emmadi, Rajyasree ^a,c   Day, Stephen P ^a,d   Klees, Robert F ^a,e   Leib, Jennifer R ^a,f   Lyon, Elaine ^a,g   Nowak, Jan A ^a,h   Pratt, Victoria M ^a,i   Williams, Mary S ^a   Klein, Roger D ^a,j  

^a Association for Molecular Pathology   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^c UNIVERSITY OF ILLINOIS HOSPITAL AND HEALTH SCIENCES SYSTEM   (United States)

^d HOLOGIC INC   (United States)

^e WADSWORTH CENTER   (United States)

^f Cavarocchi Ruscio Dennis Associates   (United States)

^g ARUP LABORATORIES   (United States)

^h NORTHSHORE UNIVERSITY HEALTHSYSTEM   (United States)

ⁱ INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j LERNER RESEARCH INSTITUTE   (United States)

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Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL LABORATORY; DIAGNOSTIC KIT; FOOD AND DRUG ADMINISTRATION; LABORATORY PERSONNEL; LAW; MEDICAL DEVICE; MEDICAL PRACTICE; MOLECULAR DIAGNOSIS; MOLECULAR PATHOLOGY; TASK PERFORMANCE;

HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; ORGANIZATION AND ADMINISTRATION; SENSITIVITY AND SPECIFICITY;

EID: 84890440612     PISSN: 15251578     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jmoldx.2013.10.003     Document Type: Article

References (5)

1. K.E. Weck, B. Zehnbauer, M. Datto, and I. Schrijver Molecular genetic testing for fragile X syndrome: laboratory performance on the College of American Pathologists proficiency surveys (2001-2009); CAP/ACMG Biochemical and Molecular Genetics Resource Committee Genet Med 14 2012 306 312
2. G.E. Palomaki, and C.S. Richards Assessing the analytic validity of molecular testing for Huntington disease using data from an external proficiency testing survey Genet Med 14 2012 69 75
3. Modernizing Laboratory Test Standards for Patients Act of 2011, H.R. 3207, 112th Cong., 1st Sess. (2011)
4. G.H. Vance College of American Pathologists proposal for the oversight of laboratory-developed tests Arch Pathol Lab Med 135 2011 1432 1435
5. Standard; Clinical Consultant Responsibilities, 42 C.F.R. Sect. 493.1419 (2012)