PHARMACOGENETCS: Identify Optimal Therapy for the Most Common Conditions

Up to 60% of depressed patients do not respond completely to antidepressants (ADs) and up to 30% do not respond at all.

Source: Frontiers in Pharmacology

Prescribing a medication for a patient without understanding how it will be processed in a their body is much like driving across the country without GPS. Advanced technology has become a necessary component of our everyday living and without it; we may not be near as efficient or effective. Likewise, advancements in molecular technology have provided us access to determine how a patient will respond to medications based off their genetic make-up. A pharmacogenetics test is a one-time test performed after obtaining a simple buccal swab from a patient and can reveal variability in the expression of the cytochrome P450 enzymes that are responsible for metabolizing 90% of medications prescribed in the U.S. This knowledge enables a provider to make personalized therapeutic decisions for patients suffering from some of the most prevalent clinical conditions like psychiatric disorders, cardiovascular disease, oncology and pain.

The only test you should order for your patient is the one that could lead to a better outcome.

3RxHoldings™ is a market leader in precision medicine, focused on diagnostic solutions that improve clinical and economic outcomes. For more information on how to embrace this testing in a compliant manner, message me at [email protected].

Genetics of drug metabolism

The cytochrome P450 (CYP) enzyme system is a group of proteins responsible for drug metabolism whose biosynthesis is controlled by a large superfamily of genes. It is involved in the metabolism of over 90% of current therapeutic drugs. There have been 7 CYP genes identified in humans thus far. These genes are all highly polymorphic, and this contributes to the vast interindividual differences in drug metabolism.

Drug Labeling and Pharmacogenetics

Over the past decade there has been increasing focus from the Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency in Japan (PMDA), and other regulatory agencies on the impact of pharmacogenetics on drug efficacy, safety, and pharmacokinetics. Those at the FDA have sought to be leaders in the United States in this area by highlighting the potential clinical implications of genetic information while also hoping to advance use of genomics in drug development to help curb the attrition of drugs during late clinical trial phases. The FDA's efforts in pharmacogenetics began in the early 2000s, with requests to the pharmaceutical industry to submit genomic information (under a voluntary genomic data submissions program) and through evaluation of approved drugs that might warrant a label revision based on pharmacogenetic data. There are now over 110 drugs for which there is pharmacogenetic information in the FDA-approved label, with the majority discussing germline polymorphisms and the remainder focused on somatic mutations and responses to anticancer drugs.

An updated listing of drugs with pharmacogenetic labeling can be found on the FDA website:(www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm) and a quick reference to information on the FDA label, along with easy access to the FDA-approved label, can be found in the Drug Labels section of PharmGKB (www.pharmgkb.org).