Clinical Chemistry
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Clinical Chemistry 50: 1526-1527, 2004; 10.1373/clinchem.2004.031625
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(Clinical Chemistry. 2004;50:1526-1527.)
© 2004 American Association for Clinical Chemistry, Inc.

Opinion

Pharmacogenomics and Pharmacogenetics: Future Role of Molecular Diagnostics in the Clinical Diagnostic Laboratory

Ralph K. Ito1,a and Laurence M. Demers2

1 Diagnostic Systems, Protedyne Corporation, Windsor, CT
2 Departments of Pathology and Medicine, Penn State University, Hershey Medical Center, Hershey, PA

aAddress correspondence to this author at: Diagnostic Systems, Protedyne Corporation, 1000 Day Hill Rd., Windsor, CT 06095. Fax 860-683-4178; e-mail ralphi@protedyne.com.

The first 20% of the full text of this article appears below.


   Introduction
 
Over the past 50 years, the clinical laboratory has evolved into a complex, technology-driven enterprise with the principal tasks of diagnosing and screening for disease, monitoring health and therapeutic response, and gauging deviations from normal physiology in humans and animals. Advances in diagnostic medicine, on the other hand, have come through the application of science and technology as a result of a coordinated effort among academia, industry, government, and private institutions. We are now entering the era of Molecular Diagnostics and Pathology, which is bringing forth the newest and most powerful science and technology available for the modern-day practice of diagnostic laboratory medicine. Among the numerous important areas to consider with molecular diagnostics are the emerging issues concerning the development of genetic assays and their use for testing individual patient responses or suitability for pharmaceutical drugs.

The definitions of pharmacogenomics (PGo) and pharmacogenetics (PGe) to be used in this context are as follows:

The distinction between the two terms has become somewhat arbitrary in the literature, and they have been used interchangeably(1); however, we wish to apply them in their proper context in the following discussion.

Recently, the US Food and Drug Administration (FDA) made recommendations to pharmaceutical companies to evaluate the PGo of their drugs. These recommendations eventually evolved into a draft guidance document(2)(3), and as a result, many pharmaceutical and biotechnology companies developed internal PGo committees to handle this aspect of drug behavior. The role of some of these committees was to review the data . . . [Full Text of this Article]


   Should pharmaceutical companies influence the development of tests used to screen potential patients for their own drug therapy?
 

   Do the pharmaceutical companies have the knowledge/capabilities required to develop complex screening tests?
 

   Who protects patient/physician medical confidentiality for PGo/PGe testing?
 

   How will PGo/PGe testing be provided?
 

   Who will pay for PGo/PGe tests?
 





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