In January, The Journal of Psychiatric Researchpublished findings from the largest-ever pharmacogenomics depression trial, which focused on the effectiveness of the GeneSight® Psychotropic genetic test.
The GUIDED Study showed that patients with major depressive disorder (MDD) were 50 percent more likely to achieve remission and 30 percent more likely to respond to treatment when their medication selection was guided by the GeneSight test.
This 24-week landmark study included nearly 1,200 patients with moderate-to-very severe depression who had failed at least one psychotropic medication. The study was conducted at 20 academic sites and 40 community sites across the United States.
Patients were divided into two treatment categories -one in which clinicians could use GeneSight test results to guide treatment decisions and another in which psychiatrists and primary care physicians prescribed medication as-usual without the benefit of genetic testing.
To get an inside look at this important study, we talked to Dr. Bryan Dechairo, executive vice president of clinical development at Myriad Genetics.
What’s the importance of the GUIDED Study?
Dr. Dechairo: The GUIDED Study was large and diverse with nearly 1,200 patients. The study was conducted at 20 academic sites, including hospitals like Mass General and Stanford, and 40 community sites – essentially putting the GeneSight Psychotropic test in the hands of the leading mental health providers in the country. It compares outcomes of patients treated by doctors doing the best they can with outcomes of patients treated by those same doctors who have the added benefit of using the GeneSight test to help guide medication selection. And we worked with the National Network of Depression Centers (NNDC) and its founding chair Dr. John Greden on both the design and execution of the study.
What were the study results?
Dr. Dechairo: When doctors used the GeneSight Psychotropic genetic test to guide their selection of antidepressants, patients experienced significantly higher rates of response and remission as well as better overall symptom relief. Also, when patients on medications in the red bin (meaning they are genetically suboptimal), were switched to green or yellow medications (genetically optimal), they had substantially better outcomes.
What new information is in the GUIDED Study?
Dr. Dechairo: The GUIDED Study found that the GeneSight Psychotropic test significantly improved remission rates when used to guide treatment decisions. The current standard of care is simply the best judgment of the doctor. Often, medication is prescribed based on previous success without genetic insight. The GUIDED Study shows that there is a better way to help patients get on the road to mental wellness faster by eliminating painful, frustrating trial and error.
Will the results of the GUIDED Study result in more people having access to the GeneSight Psychotropic test?
Dr. Dechairo: Yes. We believe patients need access to the GeneSight test. Insurance companies are the gatekeepers. While many commercial and government insurers cover the GeneSight Psychotropic test, there are still a number of insurance companies who do not cover the test. However, these results have met or surpassed the high bar set by insurers. We will continue to share these study results confirming the validity of the GeneSight Psychotropic test with potential insurers.
The publication of study results in the Journal of Psychiatric Research should open that gate wide, as it required peer-review and deep scrutiny by leading medical researchers in the field. In fact, the publication required the same high-level of evidence that the medications themselves must demonstrate for government approval.
We believe that insurance companies will ultimately want to cover the GeneSight Psychotropic test because by getting on the right medication faster, patients will spend less time and money on the wrong medications. In the end, that’s a win/win for both.
What will Myriad do with this data?
The GUIDED Study supports with overwhelming evidence that moving a patient from a red bin medication to one in the green or yellow bin significantly improves outcomes. We will continue to work with providers, professional associations, insurers, and government bodies to increase access to this potentially life-changing test.
The GUIDED Study results published in the Journal of Psychiatric Research are available here.
For more information on the GeneSight test, visit us here.