New Publication Demonstrates GeneSight Improved All Clinical Outcomes Using HAM-D6 Analysis in Large Prospective GUIDED Study


Myriad Genetics, Inc. recently announced that a new analysis of the GUIDED clinical trial using the 6-item Hamilton Depression Rating Scale (HAM-D6) was published online in BMC Psychiatry. The key finding is the HAM-D6 scale identified statistically significant improvements in all three clinical endpoints – remission, response, and symptoms – between GeneSight-guided care and treatment-as-usual at Week 8.

“The HAM-D6 scale has been shown to be a better measure of core depressive symptoms than the HAM-D17 scale,” said Boadie W. Dunlop, MD, one of the study investigators and associate professor of Psychiatry and Behavioral Sciences at Emory University School of Medicine. “This post hoc analysis provides further evidence that the GeneSight test led to significant and clinically meaningful improvements in clinical outcomes for patients with major depressive disorder relative to treatment-as-usual care.”

The GUIDED study was the largest prospective study to assess the benefit of pharmacogenomics-guided treatment for depression using the GeneSight Psychotropic test versus an active therapy control arm. All patients in the GUIDED study had the 17-item HAM-D17 questionnaire administered by blinded off-site raters as part of the study protocol. The 6-item HAM-D6 score represents a subset of HAM-D17 questions that have been shown to be more directly linked to depression. For example, questions such as “have you had trouble sleeping” that could be associated with conditions other than depression are excluded from the HAM-D6 score. Clinical studies have shown that the HAM-D6 score is superior to HAM-D17 at discriminating antidepressants from placebo.

GeneSight Psychotropic is a pharmacogenomic test that analyzes clinically important variations in DNA. The results of the test can inform doctors about genes that may impact how their patients metabolize or respond to depression medications.

Myriad Genetics Inc., is a leading precision medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five critical success factors: building upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally, and improving profitability with Elevate 2020. For more information, visit www.myriad.com.