American Association for Clinical Chemistry
Improving healthcare through laboratory medicine
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

Published Guidelines
Access to Table of Contents

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.

Committee (Author) Disclosures  

NACB Committee Members:

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.