Pharmacogentic

Pharmacogentic Testing is the scientific study of how an individual’s genes affect their response to specific drugs. The objective is to revolutionize how medications are prescribed by doctors and provide a more personalized solution. To provide a reliable medicine management tool to help patients avoid adverse drug reactions, maximize drug efficacy, improve the cost to benefit ratio and ultimately insure that patients are receiving the proper drug and dosage. Through our integrated services platform, along with our strategic industry partners we work closely with leading physicians, medical groups, hospitals and healthcare organizations. We provide pharmacogenetic testing services and support to aid physicians in determining the right medication and dosage. Our clinical scientists are licensed and all testing is performed in CAP and CLIA certified clinical laboratory to provide a gold standard level of service.

“Each year in the United States, 8.6 million Adverse drug reactions occur, resulting in more than 100,000 deaths.”

Not all people respond to the standard dose. Personalized prescribing helps your doctor select the right drug and right dose. Pharmacogentic (PGx) testing help to deliver the right medication to the right patient. Provide safer medications and determine more appropriate drug doses for patients.

There are numerous benefits to testing suitable patients which include earlier identification of non-responders,

•  targeted therapy for major illnesses,
• reduce adverse drug events,
• drug to drug interactions,
• maximize therapeutic benefits
• improve healthcare while reducing overall medical costs.

It is proving to be an invaluable medication management tool helping to guide physicians prescribe the most effective medication for patients in need.

The majority of the drugs are metabolized through the liver, and what has been scientifically proven is that over 50% of the drugs that are prescribed are metabolized through the CYP450 cytochrome system not all people respond the same to a standard dose of medication. The key reason why one would be tested is because they are on multiple medications (polypharmacy) because people on multiple medications have a higher chance that the drug will not be metabolized correctly and or having adverse reactions to current drugs. This same class of people have a greater chance for adverse drug reactions (ADR’s).

They are 4 types of Metabolizer

Diffrences in drug Metabolism Lead

The liver’s enzyme system is commonly called the cytochrome P450 system. A system that is responsible for metabolizing various medications, nutrients, dietary and herbal supplements. Drug metabolism via CYP450 enzymes exhibits genetic variability (polymorphism) that influences a patient’s response to a particular drug. The P450 (CYP 450) enzyme system is a superfamily of enzymes that can be inhibited or induced by drugs which in turn can impede the development of drug to drug interactions and possibly cause unexpected adverse drug reactions or therapeutic failures. The CYP450 enzymes are vital for the production of various agents including cholesterol and steroids. These enzymes are necessary to ensure the metabolism of drugs as well as the detoxification of foreign substances. CYP450 enzymes are membrane-bound proteins; there are more than 50 CYP450, of which the CYP1A2, CYP2C19, CYP2D6, CYP1A2, CYP3A4, and CYP3A5 enzymes are responsible for metabolizing 45% of drugs. The CYP2D6 (20–30%), the CYP2C9 (10%) and the CYP2E1 and CYP1A2 (5%) complete this enzyme system. Drugs that cause CYP450 drug interactions are called inducers. When an inducing agent is prescribed with another medication, the dosage of the other medication may need to be adjusted since the rate of metabolism is increased and the effect of the medication reduced. This can lead to a therapeutic failure of the medication. Should the medication be taken with an agent that inhibits its metabolism, the drug level can rise, which can result in a harmful or adverse drug reaction.

CYP450 inducers or inhibitors are commonly ingested items such as grapefruit juice, alcohol and tobacco. Using grapefruit juice as an example, there are a number of medications know to interact with grapefruit juice such as statins, antiarrhythmic agents, immunosuppressive agents, and calcium channel blockers. The inhibition of the enzyme system appears to be dose dependent; therefore, the more a patient drinks, the more the inhibition that occurs.

CYP2D6-metabolized drugs

Important CYP2D6-metabolized drugs with narrow therapeutic ratios:

• Anti-depressants (amitriptyline, clomipramine, desipramine, imipramine, paroxetine)
• Anti-psychotics (chlorpromazine, haloperidol, perphenazine, risperidone, thioridazine)
•  Beta blockers (carvedilol, propafenone, timolol).

CYP2C19-metabolized drugs

Important CYP2C19-metabolized drugs with narrow therapeutic ratios:

•  Anti-épileptiques (amitriptyline , clomipramine, cyclophosphamide, diazepam, imipramine, moclobemide, phenytoin, phenobarbitone, primidone, R-warfarin)
• Proton pump inhibitors (e.g., lansoprazole, omeprazole, pantoprazole).
• Others (clopidogrel).

Drug labeling is a very import reason to screen. The FDA has put Black Box Warnings on certain medications which require pre-therapeutic PGx testing before administering for therapeutic benefit. Please see the link below for a detailed list-
http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm

In the United States, a boxed warning (sometimes ‘black box warning’, colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a ‘box’ or border around the text.
The medication can cause serious undesirable effects (such as a fatal, life-threatening or permanently disabling adverse reaction) compared to the potential benefit from the drug. Depending on your health condition, you and your doctor would need to decide if the potential benefit of taking the drug is worth the risk.

Other reasons to be aware of to screen-

• Adverse Drug Reactions
• Drug Therapy Failure
• 4 or More Medications
• When the person just does not feel well because of the medication therapy

The process to start a test is as simple as 1,2 & 3

1. Perform a non invasive buccal swab on the patient – takes 20 seconds on each side of the cheek.
2. Sample gets overnighted to our lab at our expense.
3. 48 hours after receipt you have results, via a secure web portal.

Details of 1-3

Paperwork

•  Complete all necessary paperwork required for test requisition form
• This includes list of current medications
• Insurance Information
• Medical Necessity form
• Place the barcode on the specimen collection tube

Collection Process

• Verify the collection tube has not been tampered with, to ensure quality.
• Insert the swab into the mouth of the patient, placing both swabs against the buccal epithelium.
• With slight pressure and vigorous stroking move the swab across the entire buccal membrane for 20 seconds.
• Repeat process on the other side with the other side of the swab again for 20 seconds.

Final steps

• Place back in the collection tube and ensure the patients name and date of birth are on the label.
• Put sample in the pre-paid envelope and call for pickup
• 48 hours after receipt we will provide the detailed report via our secure web portal.