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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.
Newer, Smaller Analyzers Will Bring Big Data to Labs
CEO SUMMARY: Clinical laboratories of all sizes are poised to become the source of much of a hospital or health system’s “big data.” At many academic center labs, greater use of genetic and molecular testing requires that more space and more staff be devoted to data management. A…
Medicare Ends Coverage for Some Pharmacogenomic Testing
WHAT THE FEDERAL GOVERNMENT giveth with one hand, it will often taketh away with the other hand. It might be argued that this is true of federal support of pharmacogenomic testing — particularly for those tests clinical labor…
Medicare Ends Coverage for Genetic Drug-Sensitivity Tests
CEO SUMMARY: Medicare’s decision to cease covering many pharmacogenomic tests puts as many as 19 million Americans who have genetic variations affecting their response to medications at risk. These medications are commonly prescribed for patients with cardiovascular disease, pain…
Pathologists Exploring Use of Diagnostic Teams
CEO SUMMARY: In the search for ways to add more value to lab testing services, pathologists and lab administrators are considering organizing diagnostic management teams within their hospitals. Such teams focus on complex cases and include…
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
December 23, 2013 “Intelligence: Late Breaking Lab News”
Saudi Arabia is the second country to embark on the goal of sequencing 100,000 human genomes. Earlier this month, the Saudi Human Genome Program was announced. Funding for the program, expected to take five years, will be provided by the Saudi Arabian national science agency. The fir…
Exome Sequencing Next “Big Thing” for Diagnosis
CEO SUMMARY: For disease diagnostics, exome sequencing is not yet routine, but geneticists are getting close. Using this technology, researchers read those parts of the human genome where about 85% of disease-causing mutations reside. By looking only at the regions that encode proteins—…
Systems Approach For Pre-Authorization Of Genetic Tests
CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there …
Physicians in Survey Recognize Lack of Genetic Test Knowledge
MOST PHYSICIANS BELIEVE they are inadequately informed about pharmacogenomics (PGx) and how to utilize genetic tests. That’s the finding of a survey of 10,303 physicians and reveals an opportunity for pathologists and clinical lab professionals to fill an unmet need. In fact, only 10% of the 10,30…
Lab M&A Deals in June Show Market Direction
CEO SUMMARY: Despite a dismal economy, the month of June spawned two interesting merger/acquisition transactions in the lab testing industry. In one case, a blood brother gobbled up a specialty diagnostics company. In another transaction, two cross-town neighbors in Kansas City m…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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