Medically reviewed by, Russell Braun RPH
Mental health issues are a major problem affecting over 43 million Americans according to the National Institue of Mental Health. That accounts for over 18% of all adults. Medications are one of the main treatments for these problems, but they are not always effective.
Currently, there are well over 100 medications used to treat depression. Consequently, how does your doctor know the right one to pick?
Our DNA makes us all unique as individuals and it also determines the reactions we have to medication. In recent years, tests have been created to help determine how our genes match up with the medications we take. It is a new field of study called pharmacogenomics (PGx). To date, there are over 270 drugs that have pharmacogenomic information in the Food and Drug Administration (FDA) label.
1. What is GeneSight test for?
GeneSight is a test of a patients genes that is paired with information about drugs for depression. The test is specifically a psychotropic test, which means it deals genes that would affect a persons mental state.
The GeneSight test is not a detailed treatment plan. Rather, it is a guide that doctors can use to determine what drug could provide the best outcome in treating the depression. The report provides categories that are color coded. Drugs fall into a category based on how they match up with your genes. The categories resemble a traffic light with red, yellow and green providing insight on how a patient may react to each drug.
The DNA cheek swab test looks at 12 different genes and provides details on how those genes will impact the breakdown of 56 drugs used to treat depression.
To date these tests have been used by 600,000 patients according to GeneSight.
2. Hard to find patient reviews
GeneSight can’t be ordered by a patient online the way many other genetic tests can today. Instead, GeneSight must be ordered by your doctor. Patients can obtain the report, but it will be sent to your doctor first so they can review the results with you. This is why direct patient reviews are challenging to find for GeneSight Psychotropic Test.
The GeneSight website does list patient reviews, but how can you be sure those are honest reviews? Leaving patients to ask, where can you go to look for information on how useful these tests are?
3. Genetic test reviews
Ever since the mapping of the human genome project started, genetic testing has become more common. This includes tests that are requested by a doctor and ones that are sold direct to consumers.
Who reviews these tests to ensure they are accurate?
The answer is they are not really regulated today. That means they are able to make claims about what they can and can’t do without oversight. History has shown in the world of health and fitness that can be a bad thing. For instance just think of all the claims made by dietary supplement products that are bogus marketing hype.
4. Who should review GeneSight?
One problem is that basing medication decisions on genes is a very new concept. Therefore, no one government agency has really taken a lead on this. That is until recently, where two primary agencies have stepped up. The Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA)
These agencies follow criteria put forth by the Genetics Home Reference as a guide for how to evaluate genetic tests. The National Library of Medicine created the Genetics Home Reference and provides a wealth of information for doctors and patients on genetic testing. Similarly, other great references for information on genetic testing include:
5. CMS Review
CMS is the largest payer of healthcare claims in the United States. You may know them better by another name, Medicare. To date, CMS has not issued formal regulations over GeneSight Psychotropic test or any other genetic test. However, a lot can be understood by looking at the way CMS covers such tests.
Typically, before a large payer will actually approve payment for tests they want to see clinical research proving that they work. This is no different than for an X-ray, MRI or CT scan. When the data shows that these test save on health care costs in the long run, the payer agrees to pay for them.
GeneSight testing is covered by Medicare and has been since 2014. Medicare has mostly people over 65 who have higher rates of depression that is treatment resistant. Because GeneSights test often is most helpful for resistant patients, Medicare will cover the cost.
Clinical Laboratory Improvement Amendment (CLIA)
CMS does regulate CLIA, a certification that labs must pass in order to do clinical testing. CLIA focuses on the analytical validity of these tests. Analytical validity means does the test really determine the presence or absence of your gene correctly.
GeneSight is certified by CLIA.
6. Other Insurers
Many private health insurance companies have decided to cover the GeneSight test as well. They look for patients that are most likely to have successful responses to the GeneSight test. The patients they are looking for fit these criteria:
- Diagnosed Major Depressive Disorder (MDD)
- Has failed at least one other medication for depression
- The gene test has no more than 15 genes taken into consideration
If large insurance companies cover the cost of the test, there is only one reason and that is they believe it works. In the patients who fit the criteria above, they would expect to recover their cost by having lower healthcare costs overall due to the depression. Many patients with depression will end up in emergency rooms or as inpatients at hospitals, both of which are very costly.
Here is a list of some major insurers that cover GeneSight Psychotropic test.
- United Healthcare
- Some Blue Cross Blue Shield
- Kroger insurance plans
7. FDA Review
For several years after genetic test hit the market, the Food and Drug Administration (FDA) took a hands off approach. Then late in 2018, the FDA released a safety communication about these tests. The concern was around companies confirming a relationship between a gene and a medications effects. These types of claims had not been made before.
The FDA regulates the claims that manufacturers of drugs and devices used for treatment of disease can make. They decided to include genetic tests under this regulation in their safety communication.
No policy in place
To date, the FDA has no set policies in place for monitoring genetic tests like GeneSight. They have created guidance for laboratory developed tests (LDT), but this is not a law. Since we are still early in the genetic testing process this is merely suggestions from the FDA and not legally enforceable.
Is GeneSight approved by the FDA?
Myriad, the company that owns GeneSight has complied with FDA guidance after the safety communication was created. They are not allowed to claim a gene impacts a drug unless there is good clinical evidence to back it up. Therefore, some drug names were removed from their reports.
Look for more regulations from the FDA on genetic tests as more research in this field is done.
8. What does the FDA recommend patients do?
- Discuss any genetic test results with your doctor.
- Do not change or stop a medication due to a genetic test report without discussing with your doctor.
9. Mental Illness groups
There are several large organizations that focus on mental illness. These organizations have issued concern with the stance the FDA has taken to regulate these genetic tests. Some of the organizations include:
- National Alliance on Mental Illness
- National Council for Behavioral Health
- Mental Health America
- Depression and Bipolar Support Alliance
- Health and Human Services
They have expressed concerns that the FDA may prevent companies from expanding innovation into genetic testing for mental health issues.
10. Does PharmGKB provide reviews?
What is PharmGKB?
PharmGKB is a resource for genetic testing information and pharmacogenomics. Pharmacogenomics (PGx) is the study of the relationship between genetic variations and how our body responds to medication.
PharmGKB collects studies and research information on genetic impacts on drug responses. Furthermore, they review the information and provides it for patients, doctors and researchers. It is funded by the National Institutes of Health. PharmGKB reviews studies that GeneSight has conducted and evaluates the evidence.
ePharmGKB also provides genetic information to the drug package insert created when when a drug is approved by the FDA. Package inserts contain the informations doctors use when prescribing drugs. Therefore, the genetic section of the package insert contains information with actions to be taken based on a genetic makeup, essentially guiding a doctors prescribing.
The information in the package insert would indicate one of the following:
- Genetic testing required: A genetic test should be done before starting the drug based on available research.
- Genetic testing recommended: Suggests that genetic testing should be considered before starting this drug, but is not required.
- Actionable PGx: The drug may have a known reason to not use in patients with a specific gene. Remember, only a subset of patients will have this gene.
- Informative PGx: There may be a gene involved in the drugs metabolism, but no research showing any differences in response to the drug at this time.
Ask your doctor or pharmacist if there is any genetic information that should be considered with the drugs you take.
11. So, is GeneSight accurate?
According to the GeneSight website, they are regulated not only by CLIA, but also the New York State Department of Health. As a result these tests GeneSights Psychotropic Test have been shown to be 99.9% accurate.
Keep in mind that number refers to the tests ability to identify your specific genes correctly that are then incorporated in the report. It does NOT mean that GeneSight is guaranteed to find the medication that will cure your depression.
For more including how much does GeneSight test cost, check out 15 Facts About Genesight Psychotropic Test for Depression and the Cost
12. How to know if a GeneSight test is right for you?
Genetic tests will be a part of the future advances in medicine. However, that doesn’t mean you should run out and pay a huge fee to get a test done if it will not benefit you.
There are a few main components that these tests need to prove before spending hard earned cash on them. The three main things to look for are:
- Analytical validity, does the test really determine the presence or absence of your gene types correctly. Also, does the test do this reliably time after time?
Example: Does your gene that metabolizes a drug look normal or abnormal?
- Clinical validity, does the gene in question really cause the problem they suggest. Has the gene they suggest been shown by research to prove the problem they are stating?
Example: Does the gene they say causes drugs to be broken down quickly and not get to the levels needed in the blood really cause that issue?
- Clinical usefulness, does the gene being called out by the test really impact the disease they claim it does.
Example: The gene for causing a drug to break down quickly may be one of many genes that can cause the issue, does the gene(s) being looked at really do what they say?
13. Other Genetic Tests
GeneSight must be ordered by your doctor. However, there are genetic tests on the market that can be ordered by anyone. These are known as direct to consumer tests. Some examples include:
These tests used to provide all kinds of medical information based on genes that they review. However, the FDA cracked down on them and since 2013 they have taken much of that information out of their reports.
While these reports are adding health information back in as more research is done, there is another way to examine the results. If you have had one of these tests done already, more information can be at your fingertips.
Promethease is a program that takes DNA information from genetic reports and pulls out the relevant details from your genetic data. Therefore, it provides a wealth of information about your specific genes that has been studied in the past.
Be careful though, as not all research studies are created equal and they certainly don’t guarantee an outcome for a disease or medication. Promethease only costs $5 to $10 which is pretty cheap to build your own personal DNA report. On top of that it only takes about 15 minutes to get your results.
If this information is really interesting to you then it is worth a read. However, be ready for a lot of medical jargon. Finally, remember that you should not make any changes to medications without consulting your doctor! This is simply another way to get at information contained in genetic reports.
Click here to get Dr. Jason Reed’s exclusive list of medication questions you MUST ask your doctor, for FREE!
Share your story
Have you tried GeneSight or other genetic testing? Did it work well for you? Did you change medications as a result? Please chime in below with your comments and thoughts.