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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.

Another Pharmacogenomic Lab Hit With Audit, Multi-million Dollar Repayment Demand

CEO SUMMARY: In 2014, during a ZPIC audit of an unnamed pharmacogenomic testing lab, a federal auditor reviewed a small number of claims that had been filed over a period of several years. Despite supporting letters from physicians, the auditor rejected those claims, then extrapolated the…

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Health System Lab Is Genotyping To Identify Best Drugs for Patients

CEO SUMMARY: One essential element of precision medicine will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Despite the reluctance of private payers …

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Pharmacogenomic testing a success at South Dakota health system

This is an excerpt from a 2,700-word article in the January 30 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: One es…

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$26 Million Recoupment from Medicare Audit Hammers Pharmacogenomic Lab

CEO SUMMARY: After Pharmacogenetics Diagnostic Laboratory LLC was audited by a Medicare Zone Program Integrity Contractor (ZPIC), it faced a $26 million repayment demand. The lab company appealed and asked for a redetermination, then filed for Chapter 11 bankruptcy protection. These devel…

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Pharmacogenomic Testing Draws $26 Million Recoupment from Medicare Audit

This is an excerpt from a 1,340-word article in the January 9 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: Phar…

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Is Pharmacogenomics Testing Unaffordable for Payers?

ACROSS THE UNITED STATES, labs that perform pharmacogenomic tests complain that both government and private payers are reluctant to issue coverage guidelines and adequate reimbursement for these assays. Yet, this new class of diagnostic lab tests is the foundation of personalized and precision medici…

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Years of Biobank Experience Pay Off for Mayo Clinic Lab

THANKS TO 10 YEARS OF EXPERIENCE, an existing infrastructure for banking patient specimens, and the unique capabilities of its clinical laboratory organization, Mayo Clinic has been awarded a five-year, $142 million grant from the National Institutes of Health. Last…

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Opportunities Ahead for Labs That Prepare

AT THE END OF EVERY YEAR, IT’S ALWAYS SMART BUSINESS FOR EVERY LAB to peer into the future specifically to identify the best clinical and financial opportunities. With the New Year just a few week…

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Investment Bank Bullish On Clinical Labs, Pathology

CEO SUMMARY: For clinical laboratories and anatomic pathology groups willing to adapt to the evolving needs of the American healthcare system, there are many positive opportunities. That’s the view of a Wall Street investment bank that just published a report on the lab testing…

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New Company Ready to Heat Up Slow Digital Pathology Market

CEO SUMMARY: There’s a new competitor in the digital pathology marketplace with ambitious plans to deliver a fully-integrated pathologist workflow solution. Inspirata, Inc., of Tampa, Florida, made its debut in March at an international pathology conference. In this exclusive i…

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