Q: What is pharmacogenetic testing?
Pharmacogenetic testing, also called DNA Drug Sensitivity Testing, is the testing of certain genes to determine how individuals might react to specific medications. With insight derived from pharmacogenetic testing, healthcare providers may decrease the need for "trial-and-error” dosing and might substantially reduce the risk Adverse Drug Events (ADEs).
Q: What drugs does Pharmacogenetic testing cover?
Genelex currently offers pharmacogenetic testing that includes the major Cytochrome P-450 enzymes as well as other genes involved in drug metabolism. Genelex's pharmacogenetic testing includes 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 a healthcare provider who is licensed and able to write a prescription (e.g. MD, DO, NP, PA) to complete the test order.
For more information about what is required to complete your test order, review our specimen collection instruction sheet.
Q: How do I interpret pharmacogenetic test results?
Both you and your provider will receive a genetic profile report and a personalized prescribing report prepared by a pharmacist that provides information on drug-drug and FDA approved drug-gene interactions. Genelex's pharmacogenetic testing includes a consultation with one of our pharmacists. A pharmacist will review the software recommendations for improvements to a patient's medication regimen. Recommendations will be made to your authorizing healthcare provider via the physician report.
Can I talk to a pharmacist about my report?
Yes. Our pharmacogenetic test includes a consultation with one of our in-house pharmacists.
Q: What does the clinical decision support tool do?
CDST software analyzes the prescription drugs, over the counter medicines and herbal remedies that you are taking in relation to your genetic profile. It assigns a patient-specific “Genetic Risk” score for drug-drug and drug-gene interactions and includes access to over 14,000 curated references and over 12,000 pharmacist advisory notes.
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 may 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
- thyroid disorder
- organ transplant
- blood pressure (high)
- cholesterol (high)
- peptic ulcer
- prostate (enlarged)
- post-Myocardial Infarction (MI) surgery
Q: What are some of the most useful genes to test?
Genelex's pharmacogenetic test currently includes 14 additional genes to help healthcare providers. Call our team (800-TEST-DNA) or talk to your healthcare provider about what makes sense for you.
Q: Will Insurance cover pharmacogenetic testing?
Commercial insurance coverage is very limited but varies by plan and provider. They may cover PGx 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. Call your insurer to check what is covered on your policy.
If you are on a high-deductible plan, ordering the pre-pay test directly from Genelex may be your 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.
Q: How has PGx testing been used up to this point?
Pharmaceutical companies regularly use PGx 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 PGx tests on patients in order to avoid serious drug side effects, reduce trial-and-error, and achieve more accurate prescribing.
PGx testing is a key part of precision medicine, and with our patient-friendly report, you are able to have a more informed discussion with their healthcare providers.
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?
Two million, two hundred thousand (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.