50% improvement in remission with GeneSight-guided care

“[T]his randomized controlled trial found that weighted and combined multi-gene pharmacogenomic testing significantly increased clinical response and remission rates for patients with Major Depressive Disorder in the guided-care arm versus Treatment As Usual. Pharmacogenomic testing predominantly helped those patients whose treatment resistance may have been related to genetically incongruent medications. Without testing, patients and clinicians are unaware of potential ongoing gene-drug interactions.”

Greden JF, et al. Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: A large, patient- and rater-blinded, randomized, controlled study. J Psychiatr Res 2019, 111:59-67.

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Patients treated by primary care physicians improved more with GeneSight-guided care than those treated by psychiatrists.

“When outcomes were considered separately for patients < 65 and ≥ 65 years of age, all outcomes were significantly improved for patients treated by primary care providers compared to psychiatrists, regardless of age group.”

Tanner JA, et al. Combinatorial pharmacogenomics and improved patient outcomes in depression: Treatment by primary care physicians or psychiatrists. Journal of Psychiatric Research 2018; 104:157–62.

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RCT showed 73% higher response rate in GeneSight-guided arm compared to unguided TAU arm.

“In the GeneSight arm, 36.0% of subjects were responders, which was defined as a 50% reduction in HAMD-17 at ten weeks, compared to 20.8% in the TAU [treatment as usual] arm (OR=2.14; 95% CI: 0.59-7.69). In the GeneSight arm, 20.0% achieved remission, defined as HAMD-17 less than or equal to 7, at ten weeks compared with the TAU arm at 8.3% (OR=2.75; 95% CI: 0.48-15.80).”

Winner JG, et al. A prospective, randomized, double-blind study assessing the clinical impact of integrated pharmacogenomic testing for major depressive disorder. Discov Med 2013 Nov; 16(89):219-27.

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Faster reduction of symptoms observed in GeneSight-directed patients.

“The guided group experienced greater percent improvement in depression scores from baseline on all three depression instruments […] compared with the unguided group. Eight-week response rates were higher in the guided group than in the unguided group on all three measurements […]. Eight-week QIDS-C16 remission rates were higher in the guided group (P = 0.03). Participants in the unguided group who at baseline were prescribed a medication that was most discordant with their genotype experienced the least improvement compared with other unguided participants (HAMD-17, P = 0.007). Participants in the guided group and on a baseline medication most discordant with their genotype showed the greatest improvement compared with the unguided cohort participants (HAMD-17, P = 0.01).”

Hall-Flavin DK, et al. Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting. Pharmacogenet Genomics 2013 Oct; 23(10):535-48.

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GeneSight subjects achieved greater reduction in depression symptoms.

“The reduction in depressive symptoms achieved within the guided treatment group was greater than the reduction of depressive symptoms in the unguided treatment group using either the QIDS-C16 (P¼0.002) or HAM-D17 (P¼0.04).”

Hall-Flavin DK, et al. Using a pharmacogenomic algorithm to guide the treatment of depression. Transl Psychiatry 2012 Oct; 2(10): e172.

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GeneSight improved antidepressant responders by 71%.

“Providing clinicians with the GeneSight interpretive report improved the proportion of antidepressant responders by 71% as compared with unguided patients. A 2.26-fold increase in the odds of clinical response was also found for the guided patients as compared with the unguided patients. These improvements paralleled changes in drug dosing or selection, in that a greater proportion of guided patients experienced medication changes. These changes resulted in 40% of the guided patients initially on red-category medications being shifted to yellow- or green-category medications, and 35% more patients prescribed green-category medications, by the study end.”

Altar CA, et al. Clinical utility of combinatorial pharmacogenomics-guided antidepressant therapy: evidence from three clinical studies. Mol Neuropsychiatry 2015; 1:125-55.

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