Laboratory Analysis and Application of Pharmacogenetics to Clinical Practice

The National Academy of Clinical Biochemistry

Laboratory Medicine Practice Guidelines

Laboratory Analysis and Application of Pharmacogenetics to Clinical Practice

Publication Date: 2010

The objective of this document is to establish practice guidelines for application of pharmacogenetics (PGx) in the practice of laboratory medicine. It presents evidence supporting the application of PGx testing to general clinical practice and specific areas of medical practice.  The committee provides guidance for PGx testing in specific clinical settings; defines potential links in the roles of PGx and therapeutic drug monitoring in clinical settings; formulates recommended guidelines for clinical laboratories introducing pharmacogenetic tests; and provides in vitro diagnostic companies guidance on clinical assays and their performance characteristics in PGx testing. 

Guidelines Committee: 

  • Roland Valdes Jr, PhD, DABCC, FACB, University of Louisville, Louisville, KY
  • Deborah A. Payne, PhD, DABMM, DABCC, FACB, Molecular Services, UniPath LLC, Denver, CO
  • Mark W. Linder, PhD, DABCC, FACB, Department of Pathology and Laboratory Medicine, University of Louisville, Louisville, KY
  • Gilbert Burckhart, PhD, Pharmacy, University of Southern California, Los Angeles, CA
  • Daniel H. Farkas, PhD, HCLD, Sequenom Center for Molecular Medicine, Grand Rapids, MI
  • Felix Frueh, PhD, Medco Health Solutions Inc, Bethesda, MD
  • Jean-Pierre Morello, PhD, Teva Neuroscience Canada, Montreal, Quebec, Canada
  • Atiqur Rahman, PhD, Division of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, MD
  • Gualberto Ruaño, MD, PhD, Genomas Inc and Hartford Hospital, Hartford CT
  • Les Shaw, PhD, Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, PA
  • Saeed Jortani, PhD, DABCC, FACB, Department of Pathology and Laboratory Medicine, University of Louisville, Louisville, KY
  • Werner Steimer, MD, PhD, Department of Clinical Chemistry and Pathobiochemistry, Institut fur Klinische Chemie und Pathobiochemie, Munich, Germany
  • Steven Wong, PhD, Department of Pathology, Medical College of Wisconsin, Milwaukee, WI
  • Jeanne Carr, PhD, Department of Pathology , St. Jude Children’s Research Hospital, Memphis, TN
This LMPG was developed by an independent committee of the NACB. Subsequent publication of these guidelines has been supported by the Academy.