Q: What is pharmacogenetic testing?
Pharmacogenetic testing, also called DNA Drug Sensitivity Testing, is the testing of certain genes to determine how individuals will react to specific medications. With insight derived from pharmacogenetic testing, healthcare providers can greatly decrease the need for "trial-and-error” dosing and can substantially reduce the risk of Adverse Drug Events (ADEs).
Q: What drugs does Pharmacogenetic testing cover?
Genelex currently offers a comprehensive polypharmacy DNA Drug Sensitivity Testing panel that includes the major Cytochrome P-450 enzymes as well as other genes involved in drug metabolism. The Genelex test and the YouScript prescribing software allows the analysis of more than 4,000 compounds including prescription drugs, over-the-counter medications, herbal supplements, vitamins, nutraceuticals and recreational drugs. The FDA has updated the label of more than 250 drugs to include pharmacogenetic information and the breadth of coverage continues to grow.
Q: Do I need a healthcare provider to order this test?
Yes, you need healthcare provider who is licensed and able to write a prescription (e.g. MD, DO, NP, PA) to complete the test order.
Q: How do I interpret pharmacogenetic test results?
Both the healthcare provider and patient will receive a genetic profile report and a personalized prescribing report prepared by a pharmacist providing recommendations for changes that may improve the patient’s treatment response. The personalized prescribing report will have been generated by YouScript, a clinical decision support tool. A pharmacist would have reviewed the software recommendations for improvements to a patient's medication regimen, such as dosage changes, monitoring for signs of drug treatment induced adverse events or alternative medications. Recommendations will be made to your authorizing healthcare provider.
This analysis gives healthcare providers the tools to better understand the potential risks of a patient’s medication regimen. If needed, healthcare providers can modify dosage or select alternate medications. Genelex includes limited access to YouScript Precision Prescribing software with each test. Within YouScript's software interface, all medications, including herbals and over-the-counter drugs, that a patient is actively taking, plus interaction and supporting clinical information will be presented.
Can I talk to a pharmacist about my report?
Tests will include a 15-minute consultation with a pharmacist as well as limited access to the YouScript prescribing software via the web and mobile device.
Q: What does YouScript software do?
YouScript's precision prescribing software analyzes every prescription drug, over the counter medicine and herbal remedy that you are taking in relation to your genetic profile. YouScript assigns a patient-specific “Genetic Risk” score for drug-drug and drug-gene interactions. YouScript includes access to over 14,000 curated references and over 12,000 pharmacist advisory notes. The effect genetic variations have on specific medications is well documented for many drugs, and not well documented for others. In general, drugs with a very narrow effective dosing range have been researched, while drugs with a wide effective range have not.
The YouScript software and Personalized Prescribing Report are clinical decision support tools intended to add to the information healthcare practitioners have available when evaluating and prescribing medications. The recommendations provided may be based on limited patient information and do not supersede sound clinical judgement. Minor interactions and small changes in drug levels that may impact the patient are generally not reported. The healthcare practitioner has responsibility for all treatment decisions independent of the available genetic test results and any information provided by YouScript software, reports or consultations.
Q: When is Pharmacogenetic testing indicated?
The FDA has updated the labels of more than 250 drugs to include pharmacogenetic information.
If a patient takes four or more medications regularly or has had an adverse reaction that resulted in a doctor or emergency room visit, then they may benefit from DNA sensitivity testing powered by YouScript. Additionally, a combination of the following conditions indicates an increased risk of adverse reactions to medications. Genelex pharmacogenetic testing can provide insight to help reduce the risk
Conditions that can put a patient at risk:
- Over 65 years of age
- Experiencing unwanted side effects from medication(s)
- Feels their medications aren’t working
- Currently taking or considering any of the medications on this list
Or, has one or more of the following medical conditions:
- acid reflux
- mental health condition
- arthritis
- cancer
- asthma/COPD
- thyroid disorder
- organ transplant
- diabetes
- osteoporosis
- blood pressure (high)
- cholesterol (high)
- migraines
- peptic ulcer
- depression
- prostate (enlarged)
- pregnancy
- post-MI surgery
Q: What are some of the most useful genes to test?
- CYP2D6 is the best-studied drug-metabolizing enzyme and affects 25% of all prescription drugs including those for depression, pain, heart disease, stroke, and breast cancer. Drugs include Prozac® (fluoxetine), Zoloft® (sertraline), Paxil® (paroxetine), Effexor® (venlafaxine) , Vicodin® (hydrocodone and acetaminophen), amitriptyline, Claritin® (loratadine), Amrix® (cyclobenzaprine), Haldol® (haloperidol), Lopressor® (metoprolol), Rythmol® (propafenone), Tagamet® (cimetidine), Soltamox® (tamoxifen), and the over-the-counter drugs, Benadryl® (diphenhydramine), and Allegra® (fexofenadine). [2]
- CYP2C9 acts on 15% of drugs in clinical use including those for heart disease, acid reflux, ulcers. Drugs include Coumadin® (warfarin), Amaryl® (glimepiride), isoniazid, sulfonamides, ibuprofen, amitriptyline, Dilantin® (phenytoin), Hyzaar® (losartan and hydrochlorothiazide), THC (tetrahydrocannabinol), naproxen, and Viagra® (Sildenafil). [3]
- CYP2C19 acts on 15% of drugs in clinical use including those for depression, heart disease, stroke. Drugs include Plavix® (clopidogrel), Soma® (carisoprodol), Valium® (diazepam), Dilantin® (phenytoin), and Prevacid® (lansoprazole).[4]
- CYP3A4/CYP3A5 act on 50% of commonly prescribed drugs. These include pain medications, statins, some chemotherapeutic drugs, and combined oral contraceptives.[5]
Genelex currently offers 28 clinically actionable pharmacogenetic tests to help healthcare providers target treatment and medications to patient’s genetics. Call our team (800-TEST-DNA) or talk to your healthcare provider about what test makes sense for you.
Q: Will Insurance cover Genelex Pharmacogenetic testing?
Commercial insurance coverage is very limited but varies by plan and provider. They may cover Pharmacogenetic testing in some diagnostic situations including adverse drug reactions or lack of response to medication, pain management, cancer management, and management of many co-morbid conditions.
Medicare coverage is limited to CYP2D6 only for patients initiating amitriptyline or Pamelor® (nortriptyline) for treatment of depressive disorders or for patients taking Xenazine® (tetrabenazine) doses greater than 50mg/day and to CYP2C19 patients with Acute Coronary Syndrome (ACS) undergoing Percutaneous Coronary Intervention (PCI) that are initiating or reinitiating Plavix® (clopidogrel) therapy. Genelex does not accept Medicare or Medicaid at this time. Medicare Advantage may cover in some instances.
If your patients are on a high-deductible plan, ordering the pre-pay test directly from Genelex may be their best option. We also offer payment plans and a Financial Assistance Program. Please call 800-TEST-DNA (800-837-8362) for cash pay pricing or purchase from the website.
The following CPT codes are provided for your guidance only, if you would like to confirm insurance eligibility in advance.
- CYP2D6 - CPT Code 81226
- CYP2C9 - CPT Code 81227
- CYP2C19 - CPT Code 81225
- CYP3A4 - CPT Code 81230
- CYP3A5 - CPT Code 81231
- CYP1A2 - CPT Code 81479, Unlisted Code
- NAT2 - CPT Code 81479, Unlisted Code
- DPD Enzyme - CPT Code 81400
- UGT1A1 - CPT Code 81350
- HLA-B*57:01 - CPT Code 81381
- TMPT - CPT Code 81335
- DPYD - CPT Code 81232
- IFNL3 - CPT Code 81283
- SLCO1B1 - CPT Code 81328
- All Other Genes - 81479 Unlisted Code
Q: How has DNA drug sensitivity testing been used up to this point?
Pharmaceutical companies regularly use DNA drug sensitivity tests in clinical trials to exclude people for whom the drug will be dangerous or ineffective or to better understand the efficacy of their offerings. Genelex also performs testing for these companies.
Medical centers around the country are using DNA drug sensitivity tests on patients in order to avoid serious drug side effects, reduce trial-and-error, and achieve more accurate prescribing. Some of the most common medical specialties using pharmacogenetics and DNA testing include oncology, psychiatry, and cardiology.
Additionally, patients are now empowered to initiate pharmacogenetic testing themselves. Patients who are experiencing adverse reactions to medications, feel that their regimen really isn't helping to reduce their symptoms, or have a family history of drug reactions, are now leveraging genetic testing to help them gain more insight and take control of their health. Pharmacogenetic testing is a key part of precision medicine, and with pharmacogenetic testing reports, patients are able to have a more informed discussion with their healthcare providers — and often achieve the goal of getting to better, faster.
Q: What are your laboratory qualifications?
Genelex is accredited by the College of American Pathologists (CAP 4344001); certified under the Clinical Laboratory Improvement Amendments (CLIA No.50D0980559); is Washington State Medical Test Site No. MTSA.FS.60671761; New York State Department of Health license no. PFI 8201; and is licensed to perform high complexity clinical testing in all US states. To view a complete list of our licensures and accreditations, visit our accreditations page.
Q: What is the impact of Adverse Drug Events?
ADEs are the fourth leading cause of death in the US, with more than 100,000 deaths per year; 2.2 million serious adverse reactions occur per year, according to a report published by the Journal of the American Medical Association report. These ADEs lead to approximately 1.3 million emergency room (ER) visits per year, and $3.5 billion excess spend of medical costs. [1]
Q: Where can I find additional research?
Explore the Resources pages for both providers and patients to access various presentations and clinical articles.
For additional information, call us at 800-837-8362