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Psych Congress  

GeneSight Psychotropic improves clinical outcomes in patients with significant gene-medication interactions: a translational quality improvement project

Josiah Allen, BA. Joel Winner, MD.
AssureRx Health, Inc.

INTRODUCTION: GeneSight Psychotropic, a multi-gene psychiatric pharmacogenomic decision support tool, has demonstrated improved patient outcomes in two published clinical trials; however, the next step in the translational process is demonstrating effectiveness in a real world community practice setting. This current practice improvement project was conducted to measure GeneSight’s impact on clinical outcomes of psychiatric patients in an outpatient private practice.

METHODS: GeneSight assays clinically relevant variants in pharmacokinetic and pharmacodynamic genes of relevance to psychiatric medications. The phenotypes derived from this assay are integrated into a composite phenotype that is used to stratify commonly prescribed antidepressants and antipsychotics into three bins: use as directed (green bin); use with caution (yellow bin); use with caution and more frequent monitoring (red bin). PHQ-9 results were collected from 43 treatment-resistant patients diagnosed with depressive or anxiety disorders who received GeneSight as part of their clinical care. PHQ-9 results before GeneSight testing were compared with results 8 weeks later, and improvement was stratified by the bin of subjects’ medication regimens.

RESULTS: The average PHQ-9 score improved 19% for all genotyped individuals over the study period. Individuals whose initial medication regimen included significant gene-drug interactions (i.e. red bin medications) showed the greatest symptom improvement (44%) following GeneSight-guided treatment modifications, compared to those with less significant gene-drug interactions (i.e. green and yellow bin medications).

CONCLUSION: Present findings in this real world community practice setting have replicated controlled clinical trials which have preferentially shown improvement in depression outcomes for patients with significant gene-medication interactions following GeneSight testing.  

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