FAQs about the GeneSight Test
About the GeneSight Test
The GeneSight test is a pharmacogenomic test. The GeneSight test report provides information about potential gene-drug interactions that may impact how a patient metabolizes or responds to medications commonly prescribed to treat depression, anxiety, ADHD and other psychiatric conditions. The GeneSight test is intended to supplement other information you consider as part of a comprehensive medical evaluation.
There are two panels:
- The GeneSight Psychotropic test analyzes how a patient’s genes may affect their outcomes with medications commonly prescribed to treat depression, anxiety, ADHD and other psychiatric conditions. The GeneSight Psychotropic test provides information about which medications may require dose adjustments, may be less likely to work for your patients, or may have an increased risk of side effects based on your patient’s genetic makeup.
- The GeneSight MTHFR test shows whether a person has a variation in MTHFR, which can predict a patient’s ability to convert folic acid to its active form.
A buccal swab is used to quickly collect a sample of the patient’s DNA. This can be done either in your office or the collection kit can be mailed to your patient.
Any patient for whom you are considering medication treatment is a candidate. Some insurance plans require that a patient has tried at least one antidepressant without success. If you would like more information about who may benefit from GeneSight, please read our white paper titled “How do I choose patients for GeneSight testing?”
We analyze clinically important genetic variations in DNA that may impact medication outcomes, as demonstrated in multiple well-designed studies. These genes include:
- Pharmacokinetic genes: CES1A1, CYP2D6, CYP2B6, CYP2C19, CYP1A2, CYP2C9, CYP3A4, UGT1A4, and UGT2B15.
- Pharmacodynamic genes: ADRA2A, SLC6A4, HTR2A, HLA-A*3101 and HLA-B*1502.
- Additional genes: COMT*
We integrate results from numerous published clinical studies, detailed pharmacology, and FDA labels. You can find a list of references here.
*COMT is provided for informational purposes.
Test results are typically available on the portal within 2 days of your patient’s sample being received at our lab.
The GeneSight Psychotropic report categorizes medications which highlight the expected level of gene-drug interactions (i.e., use as directed, moderate gene-drug interaction, significant gene-drug interaction). Clinical considerations are provided which state the rationale for a medication’s classification. Clinical considerations can help inform treatment decisions and provide information about how medications affected by genetic variation might be best used. The patient’s specific genetic results for both pharmacodynamic and pharmacokinetic genes are also provided.
Medications in the Significant Gene-Drug Interaction category may require dose adjustments in order to have the desired effect, may be less likely to work, or may cause side effects, but that doesn’t mean they definitely won’t work or can never be used. The clinical considerations can provide rationale for a medication’s classification and considerations for treatment adjustments. Sometimes a healthcare provider may be able to overcome the reason the medication falls in the significant gene-drug interaction category, but other times it may not be the best option for a patient.
Clinical considerations provide valuable information about why a medication does not fall in the green category. Based on an individual’s genetic variation, a medication may be moved out of the green category, and into the yellow or red category, depending on how significantly the variation is expected to impact outcomes with that medication. When this happens, the medication is labeled with one or more clinical considerations, which can help inform treatment decisions. Read a more complete explanation of the clinical considerations.
No. The cost is borne by the patient, their insurance company, or a combination of both. We bill the patient directly.
95 percent of our patients pay $330 or less for the GeneSight test. The GeneSight Promise is that if we determine a patient’s out-of-pocket cost to be greater than $330, we will contact them before processing the test.
Medicare will cover the GeneSight Psychotropic test if you are considering one or more medications that have gene-drug interactions recognized by CPIC and/or the FDA. You must also be considering the PGx test as part of a broader treatment plan inclusive of non-genetic factors.
We offer a Financial Assistance Program for those with commercial insurance. If a patient is uninsured, they can call our Customer Service team to discuss how we can help at 866.260.2394. You can learn more details at genesight.com/cost/.
The clinical validity, clinical utility and economic utility of the GeneSight Psychotropic test have been evaluated in multiple peer-reviewed publications. In fact, it’s the only neuropsychiatric pharmacogenomic test backed by such extensive research. It is important to note that not all patients who received a GeneSight Psychotropic test experienced improved outcomes.
However, overall, GeneSight Psychotropic helped improve outcomes compared to treatment as usual.
These studies are available for review here.
Yes. We take privacy and security very seriously. That’s why we analyze all GeneSight Psychotropic and GeneSight MTHFR tests at our own accredited lab, so we can ensure the quality and security of your patients’ tests. Their genetic information is private and protected through various federal laws including HIPAA (Health Insurance Portability and Accountability Act) and GINA (Genetic Information Nondiscrimination Act) that ensure the security of personal and genetic information. Learn more here: https://genesight.com/privacy-policy/
We remove all personal identifiers from the patient’s samples soon after they are received in the lab. Later, the de-identified samples may be used for test validation, education, and research and development. All patient samples are disposed after 60 days.
Patients can also request that their sample be destroyed immediately by contacting us at 866.260.2394.
The GeneSight lab is CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists) Accredited.