Clinically Validated Technology
GeneSight® Science Summary
Assurex Health, the leader in neuropsychiatric pharmacogenomic testing, is the only company in the category with multiple peer-reviewed, published studies. We have robust clinical evidence that GeneSight testing is effective at getting patients on the right medication faster and that its use by healthcare providers to help guide treatment for patients is cost effective. Eight peer-reviewed publications are presented here. Three are prospective studies that evaluated both clinical utility and validity of GeneSight, one is a meta analysis of those three studies, and three look at the cost effectiveness (economic utility) of GeneSight. One other study demonstrates the superior clinical utility and validity of GeneSight’s combinatorial approach compared to single-gene analysis.
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
Clinical Outcomes: Patients experienced 70% greater improvement in depressive symptoms when GeneSight guided their treatment compared to unguided treatment as usual (TAU).
Study Design: This was a prospective cohort study of 165 subjects with a primary diagnosis of major depressive disorder.* The study compared 8 weeks of treatment guided by GeneSight to unguided treatment as usual (TAU).
Significant improvement in depression scores: Greater reduction in depression ratings was observed across the duration of the study for the GeneSight guided group, showing 70% greater improvement in depressive symptoms compared to TAU at 8 weeks.
Higher response rates: When clinicians used the GeneSight report to guide treatment, patients were 2.1 times more likely to respond to their medications compared to treatment without GeneSight.
Higher physician and patient satisfaction: Almost three times as many physicians in the GeneSight guided group perceived their patients to be very highly satisfied with their care compared to the unguided group. Physician reporting of confidence in choice of medication and treatment and satisfaction with care was also substantially higher in the GeneSight guided group.
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
Clinical Outcomes: When physicians’ decisions were guided by GeneSight, likelihood of response was more than double unguided treatment as usual (TAU). Over 70% of patients who have failed one or more antidepressants were prescribed a genetically sub-optimal medication.
Study Design: This was a double-blind, randomized controlled trial of 49 subjects with a primary diagnosis of major depressive disorder.* It compared 10 weeks of treatment guided by GeneSight with unguided treatment as usual (TAU).
Higher response and remission rates: When physicians’ decisions regarding medication change were guided by GeneSight, the likelihood of response and remission was more than double the TAU group.
GeneSight can predict patients’ response to medications: GeneSight accurately predicted those patients who were more likely to have poor depression outcomes due to gene-drug interactions. TAU subjects who had been prescribed medications that were genetically sub-optimal had almost no improvement in depressive symptoms over the 10 weeks of the trial.
Genetically optimal medications significantly improve patient outcomes: When subjects who had been on genetically sub-optimal medications were switched to a genetically optimal medication(s) based on their GeneSight report, the subjects experienced a 33.1% improvement in symptoms (HAM-D17) at ten weeks compared to red category TAU subjects who had 0.8% improvement.
Patients benefit when clinicians have access to meaningful pharmacogenomic information: Depression outcomes improved for patients when clinicians were provided and acted on pharmacogenomic information to make genetically appropriate treatment adjustments.
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.
Clinical Outcomes: Patients saw up to a 4-fold greater improvement in depressive symptoms when their treatment was guided by GeneSight.
Study Design: This was a prospective cohort study of 44 adults with a primary diagnosis of major depressive disorder.* The study compared 8 weeks of treatment guided by GeneSight to unguided treatment as usual (TAU).
Faster time to improvement: Physician medication changes guided by GeneSight pharmacogenomic testing improved time to depression symptom relief compared to current standard of care.
Genetically optimal medications prescribed more often: When clinicians used GeneSight to guide treatment, subjects were more often prescribed medications identified as genetically optimal for that subject.
Improved clinical outcomes: This study showed a 4-fold greater improvement in subjects’ depressive symptoms at week 8 (QIDS-C16) when treatment was informed by GeneSight compared to treatment as usual (TAU).
Altar C.A., et al Clinical Utility of Combinatorial Pharmacogenomics-Guided Antidepressant Therapy: Evidence from Three Clinical Studies. Mol Neuropsychiatry 2015;1:125-155 doi:10.1159/000430915
Meta-Analysis Outcomes: Analysis shows patients on GeneSight-identified genetically discordant medications show only modest improvement, while patients on more genetically aligned medications show significantly better outcomes. The odds of clinical response more than doubled when GeneSight was used to guide medication choices.
Meta-Analysis Design: Analysis shows patients on GeneSight-identified genetically discordant medications show only modest improvement, while patients on more genetically aligned medications show significantly better outcomes. The odds of clinical response more than doubled when GeneSight was used to guide medication choices.
GeneSight categorization accurately identifies patients who will not respond well to specific medications. Test subjects who were prescribed medications identified by GeneSight as discordant (red category) improved only 12.0% while patients on yellow category or green category medications improved by 32.5% and 28.5% respectively.
GeneSight guided treatment is superior to treatment as usual (TAU): The odds of a clinical response were increased 2.3-fold among all GeneSight-guided compared to all TAU subjects. The GeneSight guided group had a 53% greater improvement in depressive symptoms and a 1.7-fold relative improvement in response versus TAU.
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 Feb 17. doi: 10.1038/tpj.2014.85. PubMed PMID: 25686762
Meta-Analysis Outcomes: GeneSight® Combinatorial Pharmacogenomic testing discriminates and predicts poorer antidepressant outcomes by depressed subjects better than do phenotypes derived from individual gene testing.
• Subjects came from the blinded, treatment as usual (TAU) groups from three previous prospective clinical outcome trials and one retrospective healthcare utilization trial.
• Subjects were divided into separate subgroups based on their medication regimen, taking into account each medication’s relevant metabolic pathways (e.g. all patients taking medications that are CYP2D6 substrates were included in the CYP2D6 subgroup). For each of these subgroups, traditional individual gene phenotypes were assigned to each subject on the basis of their allelic variants (e.g. poor, intermediate, extensive, or ultrarapid CYP metabolizer).
• Based on their medication regimens, subjects were classified according to GeneSight’s green (“use as directed”), yellow (“use with caution”) or red (“use with caution and with more frequent monitoring”) categories, which was compared to the classification described above.