Myriad Genetics announces publication of GUIDED study of GeneSight in treatment-resistant major depressive disorder

Myriad Genetics announced Friday the publication of the GUIDED study data, which showed that GeneSight improves clinical outcomes in patients with treatment-resistant major depressive disorder (MDD). CEO Mark C. Capone remarked that the publication in the Journal of Psychiatric Research "represents a major milestone for Myriad and a significant advance for pharmacogenomic testing." 

The 24-week study, of which results were initially presented at the American Psychiatric Association (APA) meeting last May, included 1167 patients with treatment-resistant MDD who had failed at least one psychotropic medication. Of the participants, 560 were placed in the GeneSight Psychotropic test arm in which clinicians used GeneSight test results to guide treatment decisions, while 607 were placed in the treatment-as-usual arm in which psychiatrists and primary care physicians prescribed medication as they normally would without the benefit of genetic testing.

The results showed that at week 8, participants in the GeneSight Psychotropic cohort had a 50 percent higher rate of remission, a 30 percent higher rate of response, and an 11 percent greater improvement in symptoms compared to those in the treatment-as-usual group. The results were durable and continued to improve through to 24 weeks, "with remission rates doubling to 31 percent, response rates reaching 44 percent, and symptom improvement increasing to 43 percent," Myriad said.

Further, study data showed that "patients have substantially better outcomes when switched from GeneSight identified red category medications that were incongruent with a patient's genetic profile," Myriad said. A subset analysis of the participants on red medications found that those who were switched to green or yellow category medications by week 8 had 153-percent higher rates of remission, 71 percent higher rates of response and 59 percent greater symptom improvement versus those who remained on red category medications.

Bryan M. Dechairo, Myriad executive vice president of clinical development, noted "the consistently strong data supporting GeneSight when compared to an optimised active drug arm is unprecedented in depression clinical studies." He added that the study "clearly" demonstrated that treatment-resistant patients with MDD do better when their therapy selection is aided by GeneSight.


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