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pharmacogenomics

Pharmacogenomics is the study of how genes affect a person’s response to drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to a person’s genetic makeup. Medical professionals and administrators hope this will save lives while also enhancing the practice of personalized medicine, in which drugs and drug combinations are optimized for each individual’s unique genetic makeup.

Many drugs that are currently available are “one size fits all,” but they don’t work the same way for everyone. Whether used to explain a patient’s response or lack thereof to a treatment, or act as a predictive tool, personalized medicine hopes to achieve better treatment outcomes, greater efficacy, minimization of the occurrence of drug toxicities and adverse drug reactions (ADRs). Adverse drug reactions are a significant cause of hospitalizations and deaths in the United States.

With the knowledge gained from the Human Genome Project, researchers are learning how inherited differences in genes affect the body’s response to medications. These genetic differences will be used to predict whether a medication will be effective for a particular person and to help prevent adverse drug reactions.

The field of pharmacogenomics is still in its infancy. Its use is currently quite limited, but new approaches are under study in clinical trials. In the future, pharmacogenomics will allow the development of tailored drugs to treat a wide range of health problems, including cardiovascular disease, Alzheimer disease, cancer, HIV/AIDS, and asthma.

The term pharmacogenomics is often used interchangeably with pharmacogenetics. Although both terms relate to drug response based on genetic influences, pharmacogenetics focuses on single drug-gene interactions, while pharmacogenomics encompasses a more genome-wide association approach, incorporating genomics and epigenetics while dealing with the effects of multiple genes on drug response.

Powerful Trends Reshaping Anatomic Path Profession

CEO SUMMARY: THE DARK REPORT presents its newest biannual review of macro trends reshaping the anatomic pathology profession. These macro trends reveal a profession undergoing change and transformation on multiple fronts. New competitors are crowding into the market, payers and accreditin…

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CYP450 Testing To Have Major Clinical Impact

CEO SUMMARY: Pharmacogenomics, companion diagnostics, “personalized prescription drug therapy”—by any name, use of molecular diagnostics to guide clinicians in the prescribing and dosing of drugs is about to expand exponentially. Some experts predict that CYP450 testing alone will …

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CYP450 Plays Major Role In Drug Metabolization

CEO SUMMARY: Each year, over 100 million new prescriptions are written for two classes of drugs with metabolic pathways affected by genetic variations in cytochrome P450. There are strong clinical arguments in favor of testing individuals for these genetic mutations to determine whether t…

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Lab Tests in Pharmacies, Genzyme, Healthe, Singing River Hospital, VA

IT IS OFTEN SUGGESTED that pharmacies are a logical place to combine laboratory testing with prescription services. Such an arrangement would be consumer-friendly and has the potential to improve patient care while lowering costs. In Great Britain, the National Health Service has launched a pilot pr…

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Picking Winners and Losers For the Molecular Test Menu

CEO SUMMARY: In the 15 years it has operated a molecular diagnostics testing program, Beaumont Reference Laboratory (BRL) has learned important lessons on how to evaluate which specific molecular assays are ready for clinical introduction. It has also learned effective ways to anticipate …

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Proteomic Tests Poised For Clinical Market

CEO SUMMARY: Proteomics-based technology is developing rapidly. The strategic collaboration announced last month between Ciphergen Biosystems and Quest Diagnostics Incorporated is potentially worth $25 million. It is an expensive bet that next-generation proteomics tests soon to enter the…

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“March 7, 2005 Intelligence: Late Breaking Lab News”

It was good news for the nine-year old boy with the rare brain tumor he named “Frankstein.” On midnight, Monday, February 14, 2005, the family received a telephone call from the surgeon who performed the biopsy on February 2, 2005. He confirmed that the biopsy was negative for cancer. What is int…

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Roche/Affymetrix Microarray Cleared for Clinical Use by FDA

MOLECULAR DIAGNOSTICS took a big step forward in December. During the month, the Food and Drug Administration (FDA) cleared the first microarray instrument system and microarray-based laboratory test for clinical use. The FDA announced on December 23, 2004 that it had cleared the Ge…

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Sysmex Anticipates Major Shifts In Laboratory Testing Market

“Innovating from our core technologies will lead Sysmex into very different areas of laboratory testing.” —John Kershaw CEO SUMMARY: Sysmex America, Inc. surprised many this year when it hired its own sales and service team and begin distribu…

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“New” Legal Landmines For Clinical Laboratories

CEO SUMMARY: HIPAA is a big “new” source of legal expo- sure for laboratories and other healthcare providers. Also, recent court decisions and changes in clinical practices are adding to the legal risk for labs. Attorney Richard S. Cooper offers insights on how laboratories can better…

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