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Pharmacogenetic Testing

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Genetic Testing and Cost-Effective Pharmacotherapy

By | Pharmacogenetic Testing, Pharmacogenomics, Precision Medicine | No Comments

Scientists worldwide collaborated on the Human Genome Project between 1990 and 2003, resulting in the identification of approximately 25,000 human genes and the sequencing of roughly 3 billion DNA pairs. Sequencing the genome has provided medical science valuable information about the human body including heredity, evolution, the genetic basis of illnesses and the ways that drugs affect diseases.

 

Genetic testing in 2001 was a time-consuming, costly undertaking, as detailed in a March 2014 article in Nature “Technology: The $1,000 genome.” Costs for sequencing the human genome have fallen from about $10 million in 2001 to under $1,000 today. The efforts of the National Human Genome Research Institute to encourage research scientists and institutions to develop cost-effective sequencing platforms has paid off. As more is understood about human genetics, disease and treatment; testing is becoming more specialized and less expensive.

 

 Types of Genetic Testing

 

According to Genome.gov, today, genetic testing is used by doctors, researchers and other medical professionals for a number of reasons: 

  1. Genetic testing is used to evaluate an individual’s risk of developing and diagnosing a disease.
  2. Prenatal testing and to screen newborns for particular diseases and disorders.
  3. Used by forensic scientists for legal identification of an individual and as a way to determine paternity.

 

Pharmacogenetic testing examines the way genetic variants affect the assimilation to medicines. The testing can help clinicians select medicines that have are more beneficial to the patient and avoid drug reaction.  Because pharmacogenetic testing identifies an individual’s genetic variants, testing with Rxight® to tailor drug therapy programs to treat specific diseases such as cancer, AIDS, heart disease and diabetes.
 

 Methods of Testing

 
There are many DNA testing laboratories that provide an assortment of DNA tests to doctors, pharmacists, other specialists and the public. Early testing, called Sanger DNA sequencing, was a painstaking process that took several weeks to produce results. Depending on the type of test and the quality of the DNA sample, newer methodologies can now deliver highly accurate results in just a few days. The development of microarray technology allows analysis of multiple samples at one time, in contrast to earlier methods that allowed analysis of only one gene at a time, as described in American Laboratory “Multistranded, Alternative, and Helical Transitional DNA and RNA Microarrays: The Next Generation”” (March 2011).
 

 Accuracy and Validity of Testing

 
The federal government regulates the safety and accuracy of genetic tests. The Clinical Laboratory Improvement Amendments require that laboratories be certified to perform specific types of DNA testing. CLIA is overseen by the Centers for Disease Control. MD Labs, certified by CLIA, uses state-of-the-art testing platforms such as UPLC-MS/MS to provide fast, reliable results for several types of molecular testing.

 

MD Labs operates Rxight pharmacogenetic testing, which provides information about genetic variants for more than 200 prescription medicines. Testing is simple. DNA samples are extracted from a cheek swab and sent to MD Labs for analysis. Patients receive a Personalized Medication Review that is interpreted by a pharmacist certified in pharmacogenetics. Keeping the report on file allows pharmacists and clinicians to select medications that are compatible with a patient’s genetic characteristics.

 

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Genetic Testing for Psychiatric Medications

By | Antipsychotics, Pharmacogenetic Testing, Psychiatric Medications | No Comments

Psychiatric medicines are an important component of treating neurological and mental health disorders including depression, attention deficit disorder and schizophrenia. Dosing of psychotropic drugs can be challenging for the clinician because there is considerable variability in patient response to a drug. This variability is due to a number of reasons including the severity of disease being treated, diet, age and interactions with other medications.  The finding were published in Psychiatry Journal “The Potential Utility of Pharmacogenetic Testing in Psychiatry” (2014).

 

Inherited genetic variants also affect the way that a drug is metabolized. Some patients experience side effects from a medicine while others may not get any therapeutic value at all. For example, up to 40 percent of patients prescribed the drug fluoxetine for depression, do not get any benefit from the medicine.  The findings were published inCurrent Psychiatry Review “Jumping on the Train of Personalized Medicine: A Primer for Non- Geneticist Clinicians: Part 3. Clinical Applications in the Personalized Medicine Area” (May 2014).
 

Importance of Pharmacogenetic Testing for Psychiatric Medicines

 
Because of the variability in patient response and the potential for adverse reactions to a drug, clinicians have traditionally used a cautious trial and error method to select an appropriate medicine and determine optimum dosing. Although this approach minimizes side effects, it also delays the amelioration of symptoms. In an effort to relieve symptoms, physicians may use several medications. Combinations of drugs may result in over medication or cause side effects due to drug interactions.  The findings were published in Dialogues in Clinical Neuroscience “Psychiatric pharmacogenomic testing in clinical practice” (Mar 2010).

 

Pharmacogenetic testing provides doctors with an important tool that helps determine which medicines are best suited to a patient’s unique medical condition. Variants of several genes are associated with differences in metabolism of psychiatric medications. Gene CYP2D6 is one of the most important phenotypes for psychiatric medicines. Amitriptyline, several antidepressants and several antipsychotics are metabolized by this gene. Other clinically important genes include CYP2C19, CYP2C9 and CYP1A2. Variations in these genes affect serum concentrations of medications which, in turn, influence drug effectiveness and the potential for adverse medication reactions.  The findings were published in Dialogues in clinical neuroscience “Psychiatric pharmacogenomic testing in clinical practice” (Mar 2010).

 

So-called poor metabolizers assimilate medicines more slowly. The low metabolic capacity may cause toxicity or result in adverse events. Ultra-rapid metabolizers eliminate the drug too quickly and these patients are less likely to derive a therapeutic benefit. Intermediate metabolizers are at a higher risk of developing drug-drug interactions. The Food and Drug Administration has issued warning and dosage recommendations for more than 30 psychiatric medicines for patients with specific genetic variants. For example, citalopram require dosage modifications for ultra-rapid metabolizers.  The findings were published in:
Dialogues in clinical neuroscience “Psychiatric pharmacogenomic testing in clinical practice” (Mar 2010; Table of Pharmacogenomic Biomarkers in Drug Labeling as reported by the FDA (Nov 2016); Current Psychiatry Review “Jumping on the Train of Personalized Medicine: A Primer for Non- Geneticist Clinicians: Part 3. Clinical Applications in the Personalized Medicine Area” (May 2014).

 

Rxight® Pharmacogenetic Testing

 
The FDA recommends  pharmacogenetic testing before administering several psychotropic medications to minimize side effects and improve therapeutic outcomes. Rxight® pharmacogenetic testing examines a patient’s DNA to identify genetic variants on 60 alleles of 18 clinically significant genes that affect drug metabolism. The test covers approximately 200 prescription medicines including psychiatric medicines listed by the FDA.

 

Patients receive a personalized medication report. The information is interpreted by a pharmacist trained in pharmacogenetics. Pharmacists coordinate with a patient’s physician to help determine a medication and dose that has the potential for greater efficacy and lower risk of adverse effects. Adherence to a drug therapy program is of particular importance for patients with psychiatric disorders. When patients know that the potential for unpleasant side effects is reduced, they may become more confident in the safety of the treatment and gain better value from the medications. The findings were published in Pharmacotherapy “Pharmacogenomic Testing for Neuropsychiatric Drugs: Current Status of Drug Labeling, Guidelines for Using Genetic Information, and Test Options” (Feb 2014).

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PharmGKB Recommends PGx Testing for Pediatric Codeine Therapy

By | Adverse Drug Reactions, Pain Medications, Pharmacogenetic Testing, Provider | No Comments

Last Tuesday the American Academy of Pediatrics (AAP) issued a statement that the dangers of codeine use in children outweigh the benefits, and formally recommended that codeine not be used in the pediatric population. Specifically, the AAP noted that children can be “ultra-rapid metabolizers” of codeine and thus suffer highly deleterious adverse effects to its active metabolites. The AAP interpretation was that the “majority” of the pediatric population runs such a risk.

 

In response, PharmGKB – a leading pharmacogenomics knowledge resource – argues that while it agrees that the variability in patient phenotypic response to codeine is important to consider, PharmGKB’s position is that rather than recommending such potentially highly beneficial treatment be ceased, the AAP ought to consider the enormous potential benefit of employing pharmacogenetic testing to assess whether indeed the individual patient is a rapid metabolizer of codeine.

 

Furthermore, PharmGKB characterized such measures as an “archaic” reaction that does not take into account that rapid metabolizers can be easily flagged through PGx, and expressed concern at the AAP’s disseminating such misinformation to the general population. Moreover, PharmGKB points out that codeine is in fact a potentially highly effective analgesic and an antitussive agent and the AAPs measure to recommend discontinuing it is misguided and a blunt, outdated and categorically misinformed response.

 

MD Labs agrees strongly with PharmGKB’s stance on the AAP decision. The Rxight® pharmacogenetic testing identifies patients who should be identified based on genetic profiles that would put them at risk for major contraindications from codeine and propose alternative medications for codeine based on their genetically modulated response to codeine therapy. The Rxight® test is based on SNP genotyping for hundreds of common prescription and OTC medications, including codeine and other opioids.

 

In contrast to the AAP’s “one-size-fits-all” recommendation to avoid codeine treatment entirely for all children, using Rxight® to screen children would help identify those who may have a negative metabolic reaction to codeine before they begin treatment. Rxight® would provide prescribing guidance for their physician to tailor the child’s treatment regimen accordingly, helping children either avoid codeine or enabling children for whom codeine is entirely safe to benefit from it.

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The Benefits of PGx Testing

By | Pharmacogenetic Testing | No Comments

The relatively new field of pharmacogenetics has allowed healthcare providers to better understand the relationship between an individual’s genetic characteristics and effective medical treatment. Genetic testing has shown that some people have genetic variances that put them at higher risk for certain diseases. Genetic variances also affect the way an individual responds to medications. Pharmacogenetic (PGx) testing is a type of DNA testing that looks at your genetic profile to determine which drugs will provide the most benefit for you, reduce the risk of side effects and reduce the potential for drug-drug interactions. Rxight pharmacogenetic testing examines your DNA to identify genetic variants that can affect drug metabolism.

 

The Rxight® pharmacogenetic testing program offers you and your healthcare providers important information about how you may respond to more than 200 prescription and over-the-counter medicines. A DNA cheek swab taken by a trained healthcare provider is sent to MD Labs for analysis. The scientific team at MD Labs uses open array technology to perform precision genetic analysis of 60 alleles on 18 genes.

 

Open array testing allows a large number of genes and alleles to be tested simultaneously with a high degree of accuracy. Only one test is needed to receive information on all the pertinent genetic variables. Other PGx testing regimens may analyze only one variable at a time, requiring multiple testing and resulting in higher costs. The Rxight PGx results show how your genetic make-up may affect drug metabolism and effectiveness.

 

You receive a Personalized Medication Review (PMR)® as part of testing. A certified Rxight pharmacist will discuss the results with you, including which medications may pose a higher risk and which are beneficial based on your unique DNA. Both the pharmacy and doctor work together to ensure that your prescription is safe and effective for you. When the PMR® is kept on file, the dispensing pharmacist can verify that the prescribed medicines are compatible with your genetic characteristics. Your pharmacist cannot alter a doctor’s prescription. Instead, a certified Rxight pharmacist can communicate with your doctor to ensure that the right medicine and right dose are prescribed.

 

Adverse drug reactions are responsible for more than 700,000 visits to emergency rooms each year in the U.S. Many patients stop taking their medicine after having an adverse reaction, forfeiting the health benefit that the medicine should provide. Your Personalized Medication Review® allows doctors to choose medicines that are safe for you to take, reducing the potential for side effects. Certain genetic variants affect how quickly a drug is metabolized by your body. If testing shows that your genes affect the rate of drug metabolism, your doctor can adjust the dosage or select another medicine without going through a process of trial and error. This also saves money on expensive prescription medicines.

 

Rxight® believes that the right dose of the right medicine right from the start is the key to effective and safe patient drug use. Because your genetic characteristics do not change, you need to be tested only one time.

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CYP2D6 metabolic rate

How Fast is Your CYP2D6?

By | Pharmacogenetic Testing | No Comments

CYP2D6 is the rather cryptic name for one of a handful of very important liver enzymes, the cytochrome P450 enzymes. Cytochrome P450 (CYP) enzymes are largely responsible for detoxifying substances that are foreign to the body. The 2D6 form of cytochrome P450 is particularly important, since in detoxifies roughly 25% of the drugs used today. Individual differences in the structure of CYP2D6 can have profound effects of the concentration and activity of drugs and vitamins.

 

How CYP2D6 Works

 
CYP2D6 is a mixed-function enzyme that breaks down
xenobiotics (molecules not normally produced by the body). CYP2D6 metabolizes (breaks down) many different xenobiotics including various antidepressants, antipsychotics, antiarrhythmics, analgesics, and beta-blockers. One of the main ways that CYP2D6 metabolizes molecules is to remove a methyl group from the drug, usually rendering it inert. In this state, the drug is usually more easily removed from the body.

 
A few drugs are actually activated by CYP2D6. When CYP2D6 removes a methyl group from codeine, for example, it turns codeine into codeine-6-glucuronide and morphine, a powerful analgesic. In fact, the codeine that is swallowed is a pro-drug, and has virtually no pain-killing properties until it is activated by the liver enzyme, CYP2D6.

 

The Many Variations of CYP2D6

 
The CYP2D6 enzyme is a large protein; its structured is determined by the CYP2D6 gene. Quite impressively, there are over 90 known genetic variations in the CYP2D6 gene, leading to different forms of CYP2D6 enzymes. This genetic variation and differences in the enzyme structure of CYP2D6 have profound clinical implications.

 

Variations in CYP2D6 Determines Drug Metabolism

 
The structure of CYP2D6 determines the speed at which drugs are metabolized, or if they are metabolized by CYP2D6 at all. The variants of CYP2D6 can be grouped into four functional categories:

 

Poor metabolizers – virtually no CYP2D6 activity
 
Intermediate metabolizers – markedly reduced CYP2D6 activity
 
Normal (extensive) metabolizers – most people fall into this category
 
Ultrarapid metabolizers – Describes a fraction of people that have much greater than normal CYP2D6 activity
 

Why Variations in CYP2D6 are Clinically Important

 
The clinical importance of these distinctions can be illustrated with two drugs, codeine and paroxetine (Paxil), an SSRI antidepressant. If you gave a CYP2D6 poor metabolizer codeine, it would have no effect, because the drug would not be activated. Conversely, if you gave a CYP2D6 poor metabolizer paroxetine, the person would have very high levels of drug in the blood, because the liver would not metabolize and detoxify it.

 

The opposite is true for a CYP2D6 ultrarapid metabolizer. A normal codeine in these individuals would cause a higher than expected level of morphine, a high rate of activation. On the other hand, paroxetine would be metabolized so quickly that it would not achieve levels in the body needed to act as an antidepressant.

 

Most people are “normal” metabolizers, so most drugs are metabolized and detoxified at an expected rate. However, CYP2D6 ultrarapid metabolizers may be unaffected by 25% of drugs on the market because they break the drugs down too quickly. CYP2D6 poor metabolizers conceivably have a worse fate. Roughly 25% of drugs on the market will reach toxic levels in the body because CYP2D6 poor metabolizers simply cannot break them down.

 

What You Can Do

 
If you have ever had a “strong reaction” to a drug or a drug “had no effect” on you, you may be a poor or ultrarapid metabolizer. Fortunately, genetic tests are now available to detect CYP2D6 variants. These results could be provide critical information for your doctor before prescribing medications.

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The Benefits of Pharmacogenetic Testing

By | Pharmacogenetic Testing | No Comments

Pharmacogenetic testing refers to a type of genetic test to predict a patient’s likelihood to experience an adverse event or not respond to a given drug. Despite revision to several labels of commonly prescribed drugs regarding the impact of genetic variation, the use of this testing has been limited in many settings due to a number of factors. As a pillar of the personalized medicine movement, pharmacogenetics for physicians is anticipated to be important across all medical specialties particularly with the increasing popularity of concierge medicine.
 
Several pharmacogenetic tests have been developed, based on the data from numerous genomic studies to correlate genetic variation with variable drug response. A handful of these tests, both protein- and DNA-based, have subsequently been approved for in vitro diagnostic testing.
 
Pharmacogenetic testing is currently available for a wide range of health problems including cardiovascular disease, cancer, diabetes, autoimmune disorders, mental health disorders and infectious diseases. PGx contributes important information to the field of precision medicine by clarifying appropriate treatments for specific disease subtypes. Tangible benefits to patients including improved outcomes and reduced total health care costs have been observed. Coverage by insurers is a critical step in achieving widespread adoption of pharmacogenetic testing. The acceleration of adoption of precision medicine in general and for pharmacogenetic testing in particular will be determined by how quickly robust evidence can be accumulated that shows a return on investment for payers in terms of real dollars, for clinicians in terms of patient clinical responses, and for patients in terms of economic, health and quality of life outcomes.
 
In 2005, the FDA approved the first pharmacogenetic test based on microarray technology for genotyping 27 alleles in CYP2D6 and three alleles in CYP2C19 genes associated with different metabolizing phenotypes. Today, pharmacogenetic testing has become an integral part of the treatment of breast cancer with trastuzumab. Overexpression of the HER2 oncogene is correlated with a poor prognosis, increased tumor formation and metastasis, as well as resistance to chemotherapeutic agents. HER2 testing predetermines patients who overexpress HER2 and who will respond to trastuzumab.
 
With rapid advances in genomic technology, costs of pharmacogenetic testing have decreased in recent years. In addition to improved treatment outcomes, genetic testing can reduce high costs related to treatment failures and severe adverse events.

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Genetic Health Testing

By | Pharmacogenetic Testing | No Comments

Have you ever had a reaction to a medicine? Headaches, nausea, drowsiness, and irritability are common side-effects of both prescription and non-prescription medications. There are many reasons that people react to medications. Age, sex, weight, and overall health are a few factors that determine how your body reacts to a medication.

 

Recent research in genetic science has shown that some people have variations in their genetic make-up that can determine a reaction to a drug. Pharmacogenetics, also known as pharmacogenomics, is the study of the way that your genetic characteristics affect the assimilation and effectiveness of drugs in your body.

 

Genetic Health Markers and Adverse Drug Events

 
Genetic testing identifies changes in the DNA of specific genes to evaluate the genetic health of an individual. Some genetic variants suggest that a person may have an increased risk for developing certain diseases. Other genetic variants may affect the action of particular drugs. Reactions to drugs constitute a serious health problem across the world. In the United States, Adverse Drug Reactions are the fourth leading cause of death. Research suggests that gene variability may account for between 20 and 95 percent of the differences in drug synthesis and effectiveness.

 

Many genetic variants that affect the way a medication acts are unique to each individual. Some people do not get any benefit from a drug, while others experience severe side effects. Genetic variants that affect drug assimilation have also been associated with specific population groups. For example, a genetic variant common in African Americans requires a higher-than-standard dose of warfarin, a commonly prescribed anticoagulant.

 

Pharmacological Testing and Personalized Drug Treatment Plans

 
There are a number of specific genes associated with drug effectiveness and response. The most common genes that affect drug metabolism are the cytochrome p450 (CYP) genes. These genes control the reaction to more than 70 percent of prescribed drugs. If you have variants of the CYP genes, you may not get the predicted therapeutic benefit of the drug, or may experience serious side effects. If the gene variant results in a slower rate of drug metabolism, the drug may build up in your body and cause a toxic reaction. If your genetic make-up causes a faster drug metabolism, the medicine may be inactivated before you receive the desired therapeutic benefit. Should you have a genetic variant that is associated with the way a medicine may perform, your doctor can devise a drug treatment plan that includes medicines and doses that are safe and effective for you.

 

Pharmacogenetic testing with Rxight® looks for variants in 60 alleles on 18 genes that affect the effectiveness and metabolic action of more than 200 commonly prescribed medicines. Medicines that are affected by gene variants include those pain, cancer, diabetes, heart disease, arthritis, attention deficit disorder and mental health. You receive a personalized medication review that details your unique genetic health characteristics. These confidential results are interpreted by a medical practitioner trained in pharmacogenetics, and can be shared with your healthcare providers at your discretion.

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Learn More About PGx Testing

By | Pharmacogenetic Testing | No Comments

The relatively new field of pharmacogenetics has allowed healthcare providers to better understand the relationship between an individual’s genetic characteristics and effective medical treatment. Genetic testing has shown that some people have genetic variances that put them at higher risk for certain diseases. Genetic variances also affect the way an individual responds to medications. Pharmacogenetic (PGx) testing is a type of DNA testing that looks at your genetic profile to determine which drugs will provide the most benefit for you, reduce the risk of side effects and reduce the potential for drug-drug interactions. Rxight® pharmacogenetic testing examines your DNA to identify genetic variants that can affect drug metabolism.

 

Benefits of Rxight® PGx Testing

 

The Rxight® pharmacogenetic testing program offers you and your healthcare providers important information about how you may respond to more than 200 prescription and over-the-counter medicines. A DNA cheek swab taken by a trained healthcare provider is sent to MD Labs for analysis. The scientific team at MD Labs uses open array technology to perform precision genetic analysis of 60 alleles on 18 genes.

 

Open Array Testing allows a large number of genes and alleles to be tested simultaneously with a high degree of accuracy. Only one test is needed to receive information on all the pertinent genetic variables. Other PGx testing regimens may analyze only one variable at a time, requiring multiple testing and resulting in higher costs. The Rxight® PGx results show how your genetic make-up may affect drug metabolism and effectiveness.

 

You receive a Personalized Medication Review (PMR)® as part of testing. A certified Rxight® pharmacist will discuss the results with you, including which medications may pose a higher risk and which are beneficial based on your unique DNA. Both the pharmacy and doctor work together to ensure that your prescription is safe and effective for you. When the PMR® is kept on file, the dispensing pharmacist can verify that the prescribed medicines are compatible with your genetic characteristics. Your pharmacist cannot alter a doctor’s prescription. Instead, a certified Rxight® pharmacist can communicate with your doctor to ensure that the right medicine and right dose are prescribed.
 

Adverse drug reactions are responsible for more than 700,000 visits to emergency rooms each year in the U.S. Many patients stop taking their medicine after having an adverse reaction, forfeiting the health benefit that the medicine should provide. Your Personalized Medication Review allows doctors to choose medicines that are safe for you to take, reducing the potential for side effects. Certain genetic variants affect how quickly a drug is metabolized by your body. If testing shows that your genes affect the rate of drug metabolism, your doctor can adjust the dosage or select another medicine without going through a process of trial and error. This also saves money on expensive prescription medicines.

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