How It Works

The human genome includes some 30,000 genes. These genes are responsible for coding of functional and structural proteins. A very small number are pharmacogenomics proteins—drug receptors, drug targets, drug metabolizing enzymes and drug transporters—important to accurate and effective medication therapy.

By testing and considering an individual’s genetics relative to the performance of drug metabolizing enzymes, targets, receptors and transporters, healthcare providers can now more precisely help patients to reach optimal drug therapy.

The Process

Step One – Analytics1
Step Two – Testing2
Step Three – Application3
 

Step One – Analytics

Along with Coriell Life Sciences, a global leader in bioinformatics, we have developed proprietary tools to help identify and assess the potential benefit to individual candidates, as well as applying to large groups to determine the potential impact of a population-wide program, including return on investment. Employers and benefit providers can see the projected impact a testing program would have on the overall health and medical expenses for their population. Following testing, results will be stored to apply to future prescribing.

 

Step Two – Testing

RxGenomix works directly with pharmacists and other healthcare providers to implement PGx testing across larger populations and for individuals identified at the point of care. We help them initiate the test itself, process the sample and have a full report returned by a CLIA-certified laboratory. The logistics are often a barrier to entry for most physicians and pharmacists, but RxGenomix is there to lead every step of the process.

 

Step Three – Application

The full lab report is best interpreted by a pharmacist who has completed the RxGenomix Training Program in Pharmacogenomics. They will review the results, apply our clinical decision support tool and add their clinical judgement to create a concise recommendation to share with the ordering provider. By working together to create a personalized prescribing plan, the pharmacist and prescriber can combine their expertise to put the patient on the optimal path to better health.

FAQs Header

2.2 million serious adverse events occur per year, according to a report published by the Journal of the American Medical Association. These ADEs lead to approximately 1.3 million emergency room (ER) visits per year, and $3.5 billion excess spend of medical costs. [1]

1 – National Human Genome Institute  – National Institutes of Health (NIH)  www.genome.gov

Some of the more common conditions treated by these medications include, but are not limited to:

  • Chronic or acute pain
  • blood pressure (elevated)
  • depression
  • anxiety
  • other mental health conditions
  • diabetes
  • cholesterol (elevated)
  • cancer
  • arthritis
  • acid reflux
  • peptic ulcer
  • acid reflux
  • migraines
  • thyroid disorders
  • asthma/COPD
  • heart attack

Some commercial insurance plans offer coverage for testing, but not all. Medicare also offers coverage for patients who qualify. 

The Food and Drug Administration (FDA) currently has pharmacogenomic information listed in the package labeling of more than 250 medications, including many of the most prescribed, and this number continues to grow. Testing can apply to prescription medications, over-the-counter medications, herbal supplements, nutraceuticals and recreational medications. 

A signed order is required to process a test. This can be approved by an MD, DO, nurse practitioner or physician’s assistant. In some states, pharmacists may also order this and other tests.

RxGenomix is not a laboratory, but rather a PGx services company. RxGenomix partners with clinical testing laboratories that are accredited by the College of American Pathologists and meet the certification requirements for high complexity testing established under the Clinical Laboratory Improvement Amendments. RxGenomix then works with pharmacists and other healthcare providers to help them integrate the PGx testing process into their practice and provide enhanced clinical services to their patients.  

Until recently, medications have been developed with the idea that each drug works pretty much the same in everybody. However, genomic research has changed that “one size fits all” approach and opened the door to more personalized approaches to using and developing medications.

Depending on your genetic makeup, some medications may work more or less effectively for you than they do in other people. Likewise, some medications may produce more or fewer side effects in you than in someone else. As this science continues to evolve, healthcare providers will be able to routinely use information about your genetic makeup to choose those medications and drug doses that offer the greatest chance of helping you. 

PGx may also help to save you time and money. By using information about your genetic makeup, healthcare providers may be able to avoid the trial-and-error approach of giving you various medications that are not likely to work for you until they find the right one. UsingPGx, the “best-fit” drug to help you can be chosen from the beginning.

Pharmacogenomics (PGx) uses information about a person’s genetic makeup, or genome, to choose the medications and drug doses that are likely to work best for that particular person. This new field combines the science of how medications work, called pharmacology, with the science of the human genome, called genomics.

Each human being has some 30,000 genes in their DNA. Our current PGx testing looks at just 23 of those. That’s it. We’re only testing for variations in these few genes that affect how your body processes medications, or doesn’t.

Our testing produces a report that tells us if the genes responsible for putting a medication to work in your body are functioning properly. If they’re not, a common drug that’s safe for most could be ineffective or even dangerous for you. PGx testing is really the only way to know this before you begin taking a drug.

The test itself is painless and non-invasive, taking only a minute or two. The sample is collected by rubbing a swab inside each cheek for about 30 seconds and sending it off to the lab. That’s all there is to it.

Nearly every test returns information that could, at some point, be beneficial to you, your physician, and your pharmacist. While this does not necessarily mean a PGx test will be relevant to a medication you are currently taking, nearly everyone tested will have a variation in their genes that applies to how your body processes medications.

RxGenomix respects your privacy, and that includes your genetic information. Even though this testing will only look at a very small set of genes limited to drug metabolism, only those involved in delivering the best healthcare for you will have access to this information and it will be used solely to create a more personalized medication plan for you. For more information, you can read about our complete privacy practices here.

Genes tested include, but aren’t limited to, the Cytochrome P450 enzymes—CYP2D6, CYP2C9, CYP2C19, CYP3A4/5, and others. Other proteins, such as VKORC1 and SLCO1B1 represent drug targets and transporters, respectively. Click here for a complete list of genes tested.

In the metabolism of drugs, an individual can be classified in one of five categories (metabolism phenotype) for each gene, based on the activity of these pharmacogenomic proteins as defined by the Clinical Pharmacogenetics Implementation Consortium (CPIC):

Normal (formerly extensive metabolizer) (NM/EM)

  • Fully functional enzyme activity.

Intermediate metabolizer (IM)

  • Decreased enzyme activity (activity between normal and poor metabolizer).

Poor Metabolizer (PM)

  • Little to no enzyme activity.

Rapid/Ultrarapid Metabolizer (UM)

  • Increased enzyme activity compared to normal metabolizers.

By considering an individual’s genetics relative to drug metabolizing enzymes, targets, receptors and transporters, healthcare providers can now apply this information to prescribing for optimal drug therapy.

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