What is GeneSight?
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 certain depression medications. The GeneSight test is intended to supplement other information you consider as part of a comprehensive medical evaluation.
What information does the GeneSight test provide?
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. 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.
How can I order the GeneSight test?
How is the patient’s DNA sample collected?
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.
What patients are appropriate to test?
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?”
Can I still order the GeneSight test if I am treating patients remotely?
What genes are included on the GeneSight Psychotropic test?
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: CYP2D6, CYP2B6, CYP2C19, CYP1A2, CYP2C9, CYP3A4, UGT1A4, and UGT2B15.
- Pharmacodynamic genes: SLC6A4, HTR2A, HLA-A*3101 and HLA-B*1502.
We integrate results from numerous published clinical studies, detailed pharmacology, and FDA labels. You can find a list of references here.
What medications are included on the GeneSight test?
How will I receive my patients’ results?
When you register with us, you will have access to a secure GeneSight portal, where you can both order tests and view your patients’ results.
How long does it take to receive the test results?
Test results are typically available on the portal within 2 days of your patient’s sample being received at our lab.
How do I interpret the GeneSight test?
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.
What does it mean if a medication is in the red, ‘Significant Gene-Drug Interaction’ column?
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.
What are the clinical considerations?
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.
Who can I call if I have a question about interpreting the report?
Is there a cost to the clinic/clinician to order the GeneSight test?
No. The cost is borne by the patient, their insurance company, or a combination of both. We bill the patient directly.
How much will the GeneSight test cost my patients? Is it covered by insurance?
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/.
Has the GeneSight test been evaluated in clinical studies?
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.
Are my patient's results private?
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/
What do you do with a patient’s genetic material after a test is completed? Is it disposed of, or saved?
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.
What type of certifications does the lab have?
The GeneSight lab is CLIA (Clinical Laboratory Improvement Amendments) and CAP (College of American Pathologists) Accredited.