HomeGenetic InsightsEvaluating the GeneSight® Psychotropic Test Evaluating the GeneSight® Psychotropic Test August 15, 2018Genetic Insights How do we know that the GeneSight® test is effective? There are multiple published studies showing the clinical validity and utility, as well as the economic utility, of the GeneSight Psychotropic test. In fact, it is the only neuropsychiatric pharmacogenomic test backed by such extensive research. The GeneSight test is a pharmacogenomic test, which predicts how you may metabolize or respond to medications commonly prescribed to treat depression, anxiety, ADHD and other psychiatric conditions. The GeneSight Psychotropic test uses a proprietary algorithm to analyze nine pharmacokinetic genes and five pharmacodynamic genes, weighing their combined influence on how a patient may metabolize or respond to 64 psychotropic medications. The panel also includes one gene (COMT) for informational purposes. Based on a patient’s unique genetic profile, GeneSight testing can help inform clinicians’ medication decisions by placing each medication into one of three color-coded categories: green “Use as Directed,” yellow “Moderate Gene-Drug Interaction,” or red “Significant Gene-Drug Interaction.” The results show which medications may require dose adjustments, may be less likely to work, or may have an increased risk of side effects based on a patient’s genetic makeup. Evaluating Pharmacogenomic Tests Pharmacogenomic tests are evaluated by four factors: analytical validity (accuracy), clinical validity, clinical utility, and economic utility. Evaluation Definition Benefit of the GeneSight Psychotropic Test Analytical Validity Ability of the test to provide the correct results. The GeneSight Psychotropic test’s accuracy is 99.8%.1 The accuracy of the GeneSight Psychotropic test is regulated by CAP, CLIA, and New York State Department of Health, and its analytical validity has been approved by each of these organizations. Clinical Validity Evaluates how well a test predicts patient outcomes. Five studies have demonstrated the clinical validity of the GeneSight Psychotropic test.2-6 A meta-analysis of three of the studies evaluating the GeneSight Psychotropic test showed that patients who were prescribed red category medications had less improvement in depressive symptoms compared to patients prescribed green or yellow category medications.7 Clinical Utility Evaluates whether a test improves clinical outcomes. Seven studies have demonstrated the clinical utility of the GeneSight Psychotropic test.2-4, 6-9 Patients who received the GeneSight Psychotropic test experienced a 50% relative improvement in remission rates and a 30% relative increase in response rates at week 8 compared to treatment as usual.6 The GeneSight Psychotropic test was shown to reduce uncertainty and increase confidence in decision-making for healthcare providers prescribing medication.7 Economic Utility Evaluates the overall cost benefit to the healthcare system of implementing a technology. One study showed that patients unknowingly taking medications in their red category had more healthcare visits, medical absence days, and disability claims, and had an average annual increase in healthcare utilization cost of $5,188 (compared to patients unknowingly taking medications in their green or yellow categories).10 Another study found that patients who received the GeneSight test saved $1,035 per year on medications compared to those who received treatment as usual.11 Questions? For more information on how the GeneSight test can help you and your physician, visit genesight.com, email us at [email protected], or phone 855.891.9415. This document is for educational purposes related to pharmacogenomics and personalized medicine only and should not be considered medical advice. The information is based on scientific opinion from industry experts and is intended to provide additional information to healthcare providers. These materials may be changed, improved, or updated without notice. Assurex Health is not responsible for any errors or omissions contained in third party content. We encourage you to contact us for specific scientific advice regarding our GeneSight® tests. You may print a copy of this document for your own personal noncommercial use. You may not copy any part of this document for any other purpose, and you may not modify any part of this document without the permission of Assurex Health. “GeneSight,” “Assurex” and associated logos are registered trademarks of Assurex Health, Inc. © 2018 Assurex Health, Inc. All rights reserved. References Jablonski MR, King N, Wang Y, Winner JG, Watterson LR, Gunselman S, Dechairo BM. Analytical validation of a psychiatric pharmacogenomic test. Personalized Medicine. 2018; epub ahead of print. doi: 10.2217/pme-2017-0094. Hall-Flavin DK, Winner, JG, Allen JD, Jordan JJ, Nesheim RS, Snyder KA, Drews MS, Eisterhold LL, Biernacka JM, Mrazek DA. Using a pharmacogenomic algorithm to guide the treatment of depression. Transl Psychiatry. 2012;2:e 172. Hall-Flavin DK, Winner JG, Allen JD, Carhart JM, Proctor B, Snyder KA, Drews MS, Eisterhold LL, Geske J, Mrazek DA. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenetics and Genomics. 2013;23(10):535-548.5. Winner JG, Allen JD, Altar CA, Spahic-Mihajlovic A. Psychiatric pharmacogenomics predicts health resource utilization of outpatients with anxiety and depression. Transl Psychiatry. 2013;3:e300. doi:10. 1038/tp.2013.2. Winner JG, Carhart JM, Altar CA, Allen JD, Dechairo BM. A prospective, randomized double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discovery Med. 2013;16(89): 219-227. Altar CA, Carhart JM, Allen JD, Hall-flavin DK, Dechairo BM, Winner JG. Clinical validity: Combinatorial pharmacogenomics predicts antidepressant responses and healthcare utilizations better than single gene phenotypes. Pharmacogenomics J. 2015;15(5):443-51. Greden, J. et al. Combinatorial pharmacogenomics significantly improves response and remission for major depressive disorder: a double-blind, randomized control trial. Poster session presented at: American Psychiatric Association Annual Meeting; 2018 May 5-9; New York, NY. Altar C, A, Carhart J, Allen J, D, Hall-Flavin D, Winner J, Dechairo B, Clinical Utility of Combinatorial Pharmacogenomics Guided Antidepressant Therapy: Evidence from Three Clinical Studies. Mol Neuropsychiatry 2015;1:145-155 Tanner JA, Davies PE, Voudouris NC, et al. Combinatorial pharmacogenomics and improved patient outcomes in depression: Treatment by primary care physicians or psychiatrists. J Psychiatr Res. 2018;104:157-162. Brown L, Vranjkovic O, Li J, Al Habbab T, Johnson H, Brown K, Jablonski MR, Dechairo BM. The clinical utility of combinatorial pharmacogenomic testing for patients with depression: a meta analysis. Pharmacogenomics. 2020. doi: 10.2217/pgs-2019-0157. Winner JG, Allen JD, Altar CA, Spahic-Mihajlovic A. Psychiatric pharmacogenomics predicts health resource utilization of outpatients with anxiety and depression. Transl Psychiatry. 2013;3:e242. Winner JG, Carhart JM, Altar CA, et al. Combinatorial pharmacogenomic guidance for psychiatric medications reduces overall pharmacy costs in a 1 year prospective evaluation. Curr Med Res Opin. 2015;31(9):1633-43. Patient MTHFR Mutations: Clinical Implications and Management Strategies MTHFR mutations—changes in the methylenetetrahydrofolate reductase (MTHFR) gene—have gained increased attention in the medical community due to their potent... Read more Patient Can an App Help Me Manage My Anxiety? Health and wellness smartphone apps have become so common that if you can name a health goal, desire or condition, you can probably find an app for it. N... Read more Patient Black Trailblazers of Psychiatry and Mental Health: A Legacy of Healing and Advocacy As we celebrate Black History Month, we want to recognize a few individuals who have made extraordinary contributions to the field of psychiatry and mental heal... Read more Patient Mindful Moments: Tips for Anxiety If a well-meaning friend or family member has ever told you to “just breathe” when you’re feeling worked up or stressed out, you’d be forgiven if you felt l... Read more Patient Hints To Help You Have A Better New Year The holidays have ended, and a new year has begun—a time when many embrace a fresh start by setting New Year’s resolutions. This year, why not consider s... Read more Patient Movement as Medicine: Solutions for Anxiety Moving forward. It sounds like a nice idea, especially when you’re feeling stuck deep in the throes of an anxiety spiral. But it turns out that physically m... Read more Patient Weight-Loss Drugs and Mental Health: What You Need to Know New medications for weight loss seem to be flying off pharmacy shelves these days. But could they be linked to mental health conditions? Researchers are ... Read more Patient 3 million patients (and counting!) have now taken the GeneSight test! We’re thrilled to share that 3 million patients (and counting!) have now taken the GeneSight test! We're so grateful to the dedicated healthcare providers who... Read more Patient The Model Minority Myth and Mental Health The model minority myth stereotypes one cultural group, typically Asian Americans, as “intelligent, hard-working, and diligent and therefore more academically, ... Read more Healthcare Provider How Clinicians Can Help Support Their Patients Who Are Being Bullied How Clinicians Can Help Support Their Patients Who Are Being Bullied Acts of bullying can cause feelings of fear, loneliness and sadness, as well as depressi... Read more Learn more Learn more about GeneSight How to talk to your provider View our clinical studies
Patient MTHFR Mutations: Clinical Implications and Management Strategies MTHFR mutations—changes in the methylenetetrahydrofolate reductase (MTHFR) gene—have gained increased attention in the medical community due to their potent... Read more
Patient Can an App Help Me Manage My Anxiety? Health and wellness smartphone apps have become so common that if you can name a health goal, desire or condition, you can probably find an app for it. N... Read more
Patient Black Trailblazers of Psychiatry and Mental Health: A Legacy of Healing and Advocacy As we celebrate Black History Month, we want to recognize a few individuals who have made extraordinary contributions to the field of psychiatry and mental heal... Read more
Patient Mindful Moments: Tips for Anxiety If a well-meaning friend or family member has ever told you to “just breathe” when you’re feeling worked up or stressed out, you’d be forgiven if you felt l... Read more
Patient Hints To Help You Have A Better New Year The holidays have ended, and a new year has begun—a time when many embrace a fresh start by setting New Year’s resolutions. This year, why not consider s... Read more
Patient Movement as Medicine: Solutions for Anxiety Moving forward. It sounds like a nice idea, especially when you’re feeling stuck deep in the throes of an anxiety spiral. But it turns out that physically m... Read more
Patient Weight-Loss Drugs and Mental Health: What You Need to Know New medications for weight loss seem to be flying off pharmacy shelves these days. But could they be linked to mental health conditions? Researchers are ... Read more
Patient 3 million patients (and counting!) have now taken the GeneSight test! We’re thrilled to share that 3 million patients (and counting!) have now taken the GeneSight test! We're so grateful to the dedicated healthcare providers who... Read more
Patient The Model Minority Myth and Mental Health The model minority myth stereotypes one cultural group, typically Asian Americans, as “intelligent, hard-working, and diligent and therefore more academically, ... Read more
Healthcare Provider How Clinicians Can Help Support Their Patients Who Are Being Bullied How Clinicians Can Help Support Their Patients Who Are Being Bullied Acts of bullying can cause feelings of fear, loneliness and sadness, as well as depressi... Read more