Large, Blinded Prospective Study Demonstrates that GeneSight Improves Clinical Outcomes in Patients with Treatment Resistant Major Depressive Disorder
SALT LAKE CITY, Utah, Jan. 4, 2019 –Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced the publication of the landmark GeneSight GUIDED study in the Journal of Psychiatric Research. The study is the first-ever prospective, large-scale, blinded, randomized controlled trial evaluating combinatorial pharmacogenomics testing in 1,167 patients with treatment-resistant major depressive disorder who had failed at least one psychotropic medication.
“The publication of the GUIDED study represents a major milestone for Myriad and a significant advance for pharmacogenomic testing,” said Mark C. Capone, president and CEO, Myriad Genetics. “The United States has a mental health care crisis and GeneSight is a clinically proven solution to improve outcomes for patients with depression.”
The study showed that at week 8, individuals in the GeneSight cohort had a 50 percent higher rate of remission (p=0.007), a 30 percent higher rate of response (p=0.01), and 11 percent greater improvement in symptoms (p=0.11) compared to those in the treatment-as-usual (TAU) group (Chart 1).
Chart 1: GeneSight Testing Improved Clinical Outcomes for Patients
Additionally, these results were durable and continued to improve through the 24 week follow-up period of the study, with remission rates doubling to 31 percent, response rates reaching 44 percent, and symptom improvement increasing to 43 percent (Chart 2).
Chart 2: Durable Outcomes that Improved Through the 24 Week Follow-Up Period
Furthermore, the study demonstrated that patients have substantially better outcomes when switched from GeneSight identified ‘red’ category medications that were incongruent with a patient’s genetic profile. A subset analysis of the patients who entered the study 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 (p=0.0067), 71 percent higher rates of response (p=0.0364), and 59 percent greater symptom improvement (p=0.0018) compared to those who remained on red category medications (Chart 3).
Chart 3: Comparison of Outcomes at Week 8 in Patients Who Entered on ‘Red’ Medications and Were Switched versus Patients Remaining on ‘Red’ Medications
“The consistently strong data supporting GeneSight when compared to an optimized active drug arm is unprecedented in depression clinical studies,” said John Greden, M.D., principal investigator, executive director of the University of Michigan’s Comprehensive Depression Center and an unpaid consultant to Assurex Health. “The GUIDED study clearly demonstrates that treatment-resistant patients with major depressive disorder do better when their therapy selection is aided by GeneSight.”
GeneSight is a laboratory-developed pharmacogenomic test that uses cutting-edge technology to measure and analyze clinically important genomic variants in the treatment of psychiatric disorders. The results of the GeneSight report can help a clinician understand the way a patient’s unique genomic makeup may affect certain psychiatric drugs. The analysis is based on pharmacogenomics, the study of genomic factors that influence an individual’s response to drug treatments, manufacturers’ FDA approved drug labels, peer reviewed scientific and clinical publications, and proven drug pharmacology. Quick turnaround time, combined with a customized report of the patient’s genomic makeup, clinical experience, and other factors can provide information to help a physician make personalized drug treatment choices for each patient. For more information about GeneSight, please visitwww.genesight.com.
About Major Depressive Disorder
Major depressive disorder (MDD) is one of the most common mental disorders and can result in severe impairments that interfere with or limit one’s ability to carry out major life activities. MDD is defined as a period of two weeks or longer during which there is either depressed mood or loss of interest or pleasure, and at least four other symptoms that reflect a change in functioning, such as problems with sleep, eating, energy, concentration, self-image or recurrent thoughts of death or suicide. TheNational Institute of Mental Healthestimates that more than 16 million adults in the United States had at least one major depressive episode in the past year and the World Health Organization (WHO) categorizes clinical depression as the world’s leading cause of disability.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized 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 strategic imperatives: build 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 on how Myriad is making a difference, please visit the Company’s website: www.myriad.com. Follow Myriad on Twitter via @MyriadGenetics.
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