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 respond to medications. The GeneSight Psychotropic test uses a proprietary algorithm to analyze 12 different genes, weighing their combined influence on how a patient responds to 56 psychotropic medications.
Based on a patient’s unique genetic profile, GeneSight testing helps guide clinicians in prescribing medications 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.”
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 99.99%.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.||Five studies have demonstrated the clinical utility of the GeneSight Psychotropic test.2-4, 6, 8 Patients whose treatment was guided by the GeneSight Psychotropic test experienced a 50% improvement in remission rates and a 30% 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.9|
|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 significantly 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).5 Another study found that patients spent an additional $1,035 per year on medications when their treatment was not guided by the GeneSight Psychotropic test.8|
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.
- 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.
- 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.
- 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.
- 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 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.
- 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.
- 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