STEPS

COLLECT

To perform testing, only a simple buccal swab is needed, rub swab inside mouth cheeks for 30 seconds,

PACKAGE

Put swab back into plastic kit and insert in small bio hazard bag, include test requisition, medication list and demographics,

SHIP

Ship swabs package to FedEx under account, directly under address, or we can arrange to pick it up.

RESULTS

DNA RESULTS

DNA results are available via a secure internet connection or can be integrated into the provider’s EMR/EHR system.

REPORTS

Reports can be automatically printed preset times for providers that prefer to review paper reports.

CLIA & HIPAA

CLIA and HIPAA compliant access.

Primary Care

Pharmacogenomics (PGx) in Primary Care-Benefits of Personalized Medicine  

Primary Care Physician frequently find themselves challenged by patients with multiple health issues who’s already taking several medications by the time they’re referred to their practice. It has been estimated that many of the drugs commonly prescribed by primary care practitioners (PCP’s) such as fluoxetine, metoprolol, warfarin, and simvastatin are affected by PGx Variation.

As a pillar of personalized medicine movement, PGx testing is anticipated to be important across all medical specialities, but particularly in primary care, where the majority of all drug prescriptions are written,

Pharmacogenomics (PGx) testing is a type of genetic testing that assess a patient’s risk of an adverse response of likelihood to respond to a given drug, informing drug selection and dosing.

Medications with Significant Pharmacogenetics Information on the FDA Label

Drug Biomarker Drug Biomarker Drug Biomarker
Amitriptyline CYP2D6 Clopidogrel CYP2C19 Metoprolol CYP2D6
Aripiprazole CYP2D6 Clozapine CYP2D6 Nortriptyline CVP2D6
Atomoxetine CYP2D6 Codeine CYP2D6 Perphenazine CYP2D6
Carisoprodol CYP2C19 Desipramine CYP2D6 Propafenone CYP2D6
Carvedilol CYP2C19 Diazepam CYP2C19 Quinidine/
Dextromethorphan
CYP2D6
Celecoxib CYP2C9 Doxepine CYP2C19 and CYP2D6 Risperidone CYP2D6
Cevimeline CYP2D6 Fluvoxamine CYP2D6 Thioridazine CYP2D6
Citalopram CYP2C19 Galantamine CYP2D6 Tolterodine CYP2D6
Clobazam CYP2C19 Iloperidone CYP2D6 Tramadol CYP2D6
Clomipramine CYP2D6 Imipramine CYP2D6 Warfarin CYP2D9

PGx Helps You Achieve Optimal Prescribing

More than fifty percent of all commonly prescribed medications are metabolized through the cytochrome pathway and as the table below demonstrates, variations are extremely common.This genetic variability is a critical aspect governing how an individual patient will respond to medications.

PGx Test Panel includes testing of all clinically significant genetic variants in CYP2D6, CYP2D9, CYP2D19,VKORC1, CYP3A4, CYP3A5, and other important drug-metabolizing genes.

PGx Helps You WIth Polypharmacy Safety-Now and in the Future

Many patients are also battling other conditions such as heart disease, psychiatric conditions, or cancer that make multiple ‘prescriptions necessary. Our body’s limited capacity to process medications is easily slowed  by competition between other drugs, supplements, and over-the-counter medications. This is further compromised in patients with genetic variations,

whether a patient is genetically a poor metabolizer or has become a poor metabolizer because of other medications, it’s been shown by prospective trials, population analyses, and the cases studies he or she can experience and increase in adverse drug events due to reduced elimination.

 

PGx Testing is Designed To:

  • Evaluate patient genetic variability that could potentially deem a particular drug ineffective
  • Determine appropriate therapy for each patient, based on their genetic variability
  • Evaluate potential drug-drug interactions and susceptibility of each patient
  • Improve informed consent by communicating current and future therapy trends specifically engineered for each individual

Psychiatry

Pharmacogenomics (PGx) in Psychiatry-Benefits of Personalized Prescribing

As a psychiatrist you may frequently find yourself challenged by patients with multiple health issues already taking several medications by the time they see you. Until recently, psychiatrists had little choice but to prescribe medications without knowing in advance how their patients might genetically respond. But no more: with personalized prescribing by PGx, you’ll know upfront what medications will likely prove to be most effective for your patient- and which ones will not. You’ll know precisely how any medications will interact with the prescribed medications.

Psychiatric Medications with Pharmacogenetics Information on the FDA label  

Drug Biomarker Drug Biomarker Drug Biomarker
Aripiprazole CYP2D6 Fluoxetine CYP2D6 Perphenazine CYP2D6
Atomoxetine CYP2D6 Fluoxetine CYP2D6 Pimozide CYP2D6
Chlordiazepoxide and Amitriptyline CYP2D6 Fluvoxamine CYP2D6 Protriptyline CYP2D6
Citalopram CYP2D19 Iloperidone CYP2D6 Risperidone CYP2D6
Clozapine CYP2D6 Imipramine CYP2D6 Thioridazine CYP2D6
Desipramine CYP2D6 Modafinil CYP2D6 Trimipramine CYP2D6
Diazepam CYP2C19 Nefazodone CYP2D6 Venlafaxine CYP2D6
Doxepin CYP2C19 and CYP2D6 Paroxetine CYP2D6

PGx Helps You Achieve Optimal Prescribing

Virtually all of the medications used to treat psychiatric conditions are metabolized by CYP2D6, CYP2D19 or CYP3A4. PGx includes testing of all clinically significant genetic variants: CYP2D6, CYP2C9, CYP2C19, CYP1A2, CYP3A4, CYP3A5, HTR2A, COMT, and ANKK1/DRD2.

 

PGx Helps You Polypharmacy Safety-Now and in the Future

Many psychiatric patients may also be battling heart disease, pain, cancer, or other conditions that make multiple prescriptions necessary. But a body’s limited capacity to process medications is easily slowed by competition between other drugs, herbals, and over-the-counters. This is further compromised in patients with genetic variations. Whether a patient is genetically a poor metabolizer or has become a poor metabolizer because of other medications, it’s been shown by prospective trials, population analyses, and cases studies they can experience and increase in adverse drug events because of reduced elimination.

 

Which Patients Benefit Most From PGx?

PGx is pharmacogenomics testing geared specifically towards the mental health professional. With up to date knowledge and research driven practices, our team is able to provide expert genetic analysis to help advert drug failure and other potential issues.

  

PGx Testing is Designed To:

  • Evaluate patient genetic variability that could potentially deem a particular drug ineffective
  • Determine appropriate therapy for each patient, based on their genetic variability
  • Evaluate potential drug-drug interactions and susceptibility of each patient
  • Improve informed consent by communicating current and future therapy trends specifically engineered for each individual

 

Health Care Providers Laboratory

Cardiology

Pharmacogenomics in Cardiology-Benefits of Personalized Prescribing

Cardiologists are frequently challenged when they consult with patients who are already taking multiple medications. Making dose adjustments or prescribing different medications are difficult, and further complicated by the fact that several U.S Food and Drug Administration (FDA) -approved medications with cardiology indications carry pharmacogenetics information on their labeling (see table below), A growing number have warning about genetic factors leading to altered patient response. Until recently, cardiologists had little choice but to prescribe medications without knowing in advance how their patient might respond. Today PGx makes it possible for physicians to know, before they prescribe, which medications will be most effective based on individual genetic profiles-and which ones will not.  

 

Cardiac Medicines with Significant Pharmacogenetics Information on the FDA Label

Drug Biomarker Drug Biomarker
Carvedilol CYP2D6 Propafenone CYP2D6
Clopidogrel CYP2C19 Propranolol CYP2D6
Isosorbide and Hydralazine NAT1; NAT2 Quinidine/ Dextromethorphan CYP2D6
Metoprolol CYP2D6 Ticagrelor CYP2C19
Prasugrel and VKORC1 CYP2D19 Warfarin CYP2C9

Warfarin Dosing

Genetics variants detected by the tests are found in approximately half of patients and are the major contributor to variation in warfarin dose requirement.

The two genes, CYP2C9 and VKORC1, are a model for the application of pharmacogenetics data because one controls the metabolism of the drug and other controls the effective concentration requirement at the site of action.

CYP2C9 Genotype Time to Stable Dose
*1/*1 extensive (normal) metabolizer 3-5 days
*1/*2 or *1/*3 intermediate metabolizer 6-8 days
*1/*3, *2/*2, *3/*3 intermediate or poor metabolizer 2-15 days
  • CYP2C9 is the most-important enzyme in the metabolism of warfarin and greatly affects the haH-life and time to a stable dose. Without the genetic testing it is not known if INR test results represent a steady state of one that is climbing.
  • Vitamin K epoxide reductase complex subunit 1, VKORC1, is the site of action of warfarin. The level of the enzyme is under genetic control according to the DNA sequence present in the control region of the gene. The more enzyme present, the more warfarin required.
  • Genotyping patients prior to warfarin therapy may reduce adverse events and improve achievement of stable INR.
  • Monitoring of the patient’s INR is still required and genetic testing for CYP2C9 and VKORC1 is not a replacement for INR monitoring.

PGx Helps You Achieve Optimal Prescribing

Many important medications used to treat cardiac conditions are metabolized by CYP2D6, CYP2C9, CYP2C19, CYP3A4 and CYP3A5. Genetic variations in these cytochromes are extremely common. This genetic variability is one of the most important considerations determining how and individual patient will respond to specific medications.

PGx tests for all clinically significant genetic variants in the enzymes responsible for metabolizing the majority of medications:   CYP2D6, CYP2C9, CYP2C19, CYP3A4, CYP3A5, and VKORC1, among others. The results of the test will enable healthcare providers to individualize therapeutic treatments of cardiovascular disorders for improved outcomes. Healthcare providers will be better able assess patient’s’ individual needs and optimize their therapy, while minimizing risks for adverse drug reactions and interactions. Some of the commonly-prescribed medications used to treat cardiovascular disease include:

  • Warfarin (Coumadin)
  • Beta Blockers
  • Clopidogrel Bisulfate (Plavix)
  • Statins

Having PGx actionable results of your patient will allow you to create a truly personalized treatment plan, which will result in better patient outcomes.

Health Care Providers Laboratory

Pain Management

Common Pain Medications with Pharmacogenetics Information on the FDA Label

Drug Biomarker
Amitriptyline CYP2D6
Celecoxib CYP2C9
Codeine CYP2D6
Desipramine CYP2D6
Doxepin CYP2C19, CYP2D6
Flurbiprofen CYP2C9

PGx Helps You Achieve Optimal Prescribing

Many opioid analgesics are metabolized into a much more active metabolite by CYP2D6 or CYP3A4, and many non-steroidal anti-inflammatory drugs (NSAIDs) are metabolized by CYP2C9. Genetic variations in these cytochromes are extremely common. This genetic variability is often the most important consideration in how an individual patient will respond to a medication. PGx est for all clinically significant genetic variants in the enzymes responsible for metabolizing the majority of medications: CYP2D6, CYP2C9, CYP2C19, CYP3A4, CYP3A5, CYP2B6, COMT, CYP1A2, and OPRM1.

 

PGX Testing Is Designed To:

  • Evaluate patient genetic variability that could potentially deem a particular drug ineffective.
  • Determine appropriate therapy for each patient, based on their genetic variability.
  • Evaluate potential drug-drug interactions and susceptibility of each patient.
  • Improved informed consent by communicating current and future therapy trends specifically engineered for each individual.

 

The goal of personalized pain management is the most effective and individualized balance at which a patient experiences maximum desirable analgesic relief and minimal undesirable adverse effects.

Pharmacogenomics (PGx)- Personalizing Pain Management

Prescribing can often be particularly challenging for pain management specialist, since chronic pain sufferers are often being treated for other conditions such as depression, addiction, or cancer. One of the fundamental goals of pain management is better control of pain without significant adverse effect from pain medications themselves. Unfortunately, safe and effective analgesia is an important unmet critical medical need and its continued existence is an important clinical, economic, and social problem. This is mainly because of huge and unpredictable interpatient variability and narrow therapeutic indices of currently used medication. Opioids are some of the most commonly used analgesics. Narrow therapeutic index and large interpatient variability in response to opioids are clinically significant, with inadequate pain relief at one end of the spectrum and serious side effects, such as respiratory depression and excessive sedation due to relative overdosing, at the other end.

Personalizing pain management attempts to maximize- pain relief, while minimizing adverse events from therapy. While various factors influence response to treatment, age, sex, race, and pharmacogenetics differences appear to play major roles in predicting outcome. Genetic factors include a subset of genes that modulate the proteins involved in pain perception, pain pathway, analgesic metabolism (pharmacokinetics), transport and receptor signaling (pharmacodynamics). We have reviewed the available evidence on improving and personalizing pain management with opioids and the significant of individualizing analgesic, in order to maximize analgesic effect with minimal adverse effects with opioids.

PGX can help prescribers improve pain management by determining each patient’s unique drug metabolizing capacity and identifying which drugs and doses are likely to be most effective in treating their pain. Until recently, pain management specialist had little choice but to prescribe medications without knowing in advance how patients might respond. Today, PGx makes it possible for physicians to know, before the prescribe, which medications will be most effective based on individual genetic profiles- and which ones will not.

 

Pharmacogenomics PGx

Pharmacogenomics is a DNA test used to determine how an individual’s genetic profile affects their response to drugs. By correlating an individual’s genetic variation, pharmacogenomics (PGx) will help in predicting particular drug’s efficacy and/or its toxicity. This kind of testing is the beginning of “personalized” or “precision medicine” in which drugs or drug combination are optimized for each individual’s unique genetic makeup. PGx has applications in any field of medication, including cardiovascular disorders, oncology, mental health, HIV, Tuberculosis, Asthma, Diabetes, and pain management. Information about genotypes linked to drug metabolism may be used as an aid to clinicians in determining the best therapeutic strategy and treatment dose.

PGx is a well researched field; there has been over 15,000 publications released about the field so far. In recent years PGx testing has seen a significant increase in clinical utility , its role in optimization of clinical trials is becoming increasingly evident as it can prevent ADRs, minimize side effects and enable cost efficiencies. It’s a welcome alternative to trial-and-error approach to medication selection. PGX information indicates optimal route, dose and/or frequency of administration and allow doctors to help manage patient medication and dosing changes more effectively. The FDA advocates clinical pharmacogenomics because of its potential to increase efficiency and safety.

 

PGx Testing Facility

  • Robotic DNA extraction and testing, to ensure high accuracy and low error
  • Proprietary test platforms and methodologies
  • Testing for more allele mutations than any other system (currently 55 markers)
  • Test variation across multiple platforms and verified by independent third party
  • Rapid 5-day turnaround time
  • Ability to test noninvasive swab samples
  • Dedicated customer service

 

During the state of the union last month President Obama talked about how the Precision Medicine Initiative, or PGx testing, will aid doctors in the near future for the treatment of different illness and disease. That’s why President Obama is giving $215 million towards this goal. The FDA has already changed the its labeled drugs because of PGx. President Obama and the FDA won’t motivate everyone to fund PGx testing; yet, hopefully society will begin questioning their physicians about testing and physicians will lobby for for a universal PGx test so we can treat and cure many debilitating diseases. Besides being able to provide the right person with the right drugs, in the right dose, at the right time within the right interval, via the right route, PGx will help us prevent Adverse Drug Reactions. These account for a large portion of the 100,000 medical facilities annually in the United States. If the PGx testing will be utilized, the physicians could actually practice precision medicine which is what Obama hopes for therefore significantly minimizing ADR fatalities.

 

Medication Therapy Management

 

Other Major Benefits of Performing PGx Testing Include:

  • Select optimal therapy and reduce “trial-and-error” medicine
  • Improve the selection of drug targets
  • Increase client compliance with therapy
  • Shift the emphasis on medicine from reaction to prevention
  • Reduce the overall cost of Healthcare
  • Provide a potential explanation the complaint of ineffective/harmful drugs
  • Forensics (overdoses)

 

PGx Can Also Be Used as a Prospective Screening Tool

  • Carried out in the absence of a pre-existing medical condition
  • Used to identify potential future hopefully preventing them from occurring
  • Screening family members of patients known to have an ADR

 

Summary

Major areas that would benefit from PGx testing include:

  • Psychiatry- antidepressants, antipsychotics
  • Anticoagulation therapy- warfarin, plaix  
  • Transplant- azathioprine
  • Oncology- tamoxifen, chemotherapeutic drugs
  • Drug addiction- nicotine
  • Pain management- opioid analgesics
  • Cardiology- beta blockers

 

PGx testing,wherein a specific genetic test is tied to the expected efficiency of a drug, are referred to as companion diagnostics (CDx), in the sense that they are “campanion”  to a particular drug;  the test is employed in assessing the likely utility of the drug treatment. These small and focused numbers, compared to the total number of the drugs on the market, should give the reader reason consider just how much room for growth there is in the CDx field. The significance of this has not been lost on drug development, or molecular diagnostics, companies , which are actively expanding in this direction. One recent report predicted a growth rate success of 18% for the field between 2013 and 2019. As this growth proceeds, clinicians will increasingly have access to highly specific molecular-based tools not just to diagnose the patient, but to select the most effective drug treatments, to guide therapeutic dose selections, and to avoid adverse drug reactions.

Clinicians understand that visible differences between patients, such as age and weight, can affect how the patient will respond to different medications. What is currently less understood are the important invisible differences that also affect therapy. A primary cause of variation in drug response is interindividual variations in the genes that encode for the “proteins and enzymes involved in the transport and metabolism of drugs”. Interindividual differences in the pharmacokinetics (PK) of drugs represent a major clinical problem. Because of these differences, plasma levels of drugs are poorly predictable, which might lead to unexpected toxicities or undertreatment of patients. By identifying these genetic variations through a one-time genetic test, we can better prescribe a pharmacotherapy regimen that is optimal for each individual patient.

Variation in the DNA encoding for these enzymes can cause them to metabolize faster or slower. Also illustrated in this Urine Drug Monitoring handbook, DNA sequence variations are associated with:

  • Lack of enzymatic activity (poor metabolizer)
  • Reduced enzymatic activity (intermediate metabolizer)
  • Enhanced enzymatic activity (ultra-rapid metabolizer)

 

Studies have shown that incorporating genetic factors into the prescribing process can help improve efficiency and reduce adverse effects. Test can be ordered as a panel, or individually. Our customized panel of PGx testing consists of 55 markers that cover over 12 genes and since it is customized, it can be changed depending on the particular requirements of the time. The star of the list is the gene called CYP2D6, since it it is directly involved in the metabolism of ~25% of all common used drugs. Two other notable cousins of this gene include two enzymes from the family: CYP2C19 and CYP2C9

 

Panels

  • Pain Panel (CYD2D6,  CYP2C9, CYP2C19, CYP3A4, CYP3A5, CYP286, COMT, CYP1A2, and OPRM1.)
  • Psychotropic Panel (CYD2D6,  CYP2C9, CYP2C19, CYP3A4, CYP3A5, CYP1A2, COMT, and ANKK1/DRD2 )
  • Comprehensive Panel includes al 55 markers
  • Cardiovascular Panel (CYD2D6,  CYP2C9, CYP2C19, CYP3A5,VKORc1, F2, Factor II, F5/Leiden, MTHRFR, VKOC1)
  • Thrombosis Panel (F2, Factor II, F5/Leiden, MTHRFR, VKOC1)
  • Oncology Panel
  • Addiction Panel
  • Transplant Panel
  • Macular Degeneration-Panel
  • Gynecology Panel

 

PGx test will select the most optimal treatment regimen for each particular patient just by doing a simple cheek swab (called buccal swab) based on the extracted DNA you will receive a customized report created specially for you, so that you can get the most benefit for you particular ailment. PGx will help to individualize medicine by helping people, who have not been able to benefit before. PGx testing is the foundation of personalized medicine and it will help us select the right drug at the right dose, for the right patient.

©2018 Health Care Providers Laboratory, Inc. All Rights Reserved