Washington, DC, August 10, 2010 The American Association for Clinical Chemistry (AACC) announces the publication of Laboratory Medicine Practice Guidelines (LMPG) on Laboratory Analysis and Application of Pharmacogenetics to Clinical Practice. In development for several years, it provides guidelines for using genetic information to develop more effective treatment plans for individual patients. Laboratory Medicine Practice Guidelines are developed by the National Academy of Clinical Biochemistry (NACB), AACC’s academy dedicated to advancing the science and practice of laboratory medicine since 1976.
Pharmacogenetics (PGx) is the study of the relationship between a person’s genetic make-up and that person’s reaction to prescribed medications. By understanding certain genes, it is possible for physicians to tailor precisely therapeutic drug regimens to the specific needs of individual patients, increasing the quality of care while decreasing the chances of expensive and dangerous adverse drug reactions. Pharmacy Benefits Management companies like Medco and CVS Caremark have embraced the use of PGx tests to improve care for millions of patients and these Guidelines now provide a framework for standardizing the use of these tests and their clinical applications. The LMPG establishes guidelines for applying PGx in the practice of laboratory medicine, presenting evidence supporting the application of PGx testing to general clinical practice and specific areas of medical practice. Guidance is provided 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.
Since 1994, the AACC has developed consensus-based guidelines for the laboratory evaluation and monitoring of patients with specified disorders. After a series of public presentations and reviews designed to reach consensus among experts, the guidelines are published and serve as the basis for moving research into clinical practice. Several LMPGs have been translated into other languages, including French, Italian, Japanese, Polish and Spanish. The guidelines are available online at no cost; print versions are available for purchase through AACC Press.
Roland Valdes, Jr., PhD, DABCC, FACB, Chair of the Guidelines Committee commented, “These guidelines establish a framework for the application of pharmacogenetics to patient care, bringing us closer to enabling the practice of personalized medicine”. Continuing, he added, “The AACC’s team of dedicated practitioners worked diligently to make this possible. This is a major milestone for the Academy and practitioners of laboratory medicine, physicians and their patients.” Dr. Valdes is a Professor and Senior Vice-Chairman of the Department of Pathology and Laboratory Medicine at the University of Louisville. He is also Professor of Biochemistry and Molecular Biology and holds the appointment of Distinguished University Scholar. He is Co-Founder and President of PGXL Laboratories, a privately-held molecular diagnostics laboratory. Dr. Valdes is also past Chair of AACC’s Personalized Medicine Advisory Group.
For more information about this important development in personalized medicine, or to arrange an interview with Dr. Valdes, contact Peter Patterson on either of the above phone numbers or at ppatterson@aacc.org.