GeneSight® Shown to Statistically Significantly Improve Generalized Anxiety Disorder Treatment Response and Decrease Benzodiazepine Use
Positive Results Presented at the 25th World Congress of Psychiatric Genetics
Salt Lake City, Oct. 19, 2017 – Assurex Health, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN), today announced new positive results for the GeneSight® test in patients with Generalized Anxiety Disorder (GAD). The study found that GeneSight guided treatment statistically significantly improved treatment response in patients with GAD and decreased the use of benzodiazepines which have potential for abuse and dependence. The data were presented at the 25th World Congress of Psychiatric Genetics meeting in Orlando, Fla with co-investigators from Toronto’s Centre for Addiction and Mental Health (CAMH).
“Anxiety is one of the most common mental health disorders, affecting 60 million Americans or three times the number of people with depression,” said Bryan Dechairo, Ph.D., executive vice president of Clinical Development, Myriad Genetics. “This new study provides strong evidence that the GeneSight test can help physicians personalize treatment for patients with anxiety, leading to more effective treatment and a beneficial reduction in benzodiazepine use.”
This study evaluated data from two separate studies including: CAMH’s Individualized Medicine: Pharmacogenetic Assessment and Clinical Treatment (IMPACT) study, where 315 patients with anxiety disorders were assessed for symptom severity using the GAD-7 questionnaire; and the Medco dataset in which 662 patients who were prescribed at least one benzodiazepine six months pretesting and were followed 12 months post-testing.
The results of the IMPACT study show that medication decisions that were congruent with the GeneSight test results can help guide the treatment of GAD and resulted in a statistically-significant improvement in anxiety symptom severity (p=0.03). The Medco data showed that 18 percent of patients originally taking at least one benzodiazepine ceased the use of benzodiazepines after testing with GeneSight with a significant decrease in benzodiazepine drug counts and refills (p<0.001). The IMPACT study was funded in part by Ontario’s Ministry of Research and Innovation.
For more information about GeneSight, please visit www.genesight.com.
Anxiety affects one in five people in the United States and one in nine people worldwide and is a leading cause of disability. Anxiety increases the risk for other conditions including depression and substance abuse. Treatment for anxiety includes psychological interventions and pharmacologic therapy. Antidepressants are considered the first line in the treatment of anxiety and benzodiazepines are considered second or third line due to the potential for abuse and dependency.
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.
About Assurex Health
Assurex Health, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN) is a personalized medicine company that specializes in pharmacogenomics and is dedicated to helping physicians determine the right medication for individual patients with neuropsychiatric and other disorders. The company was founded to commercialize industry-leading personalized medicine technology for neuropsychiatric disorders. Assurex Health has licensed technology from Mayo Clinic and Cincinnati Children’s Hospital Medical Center.
For more information about Assurex Health, please visit https://genesight.com/about-assurex-health/.
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 three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra DA, GeneSight, EndoPredict and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G
About CAMH The Centre for Addiction and Mental Health (CAMH) is Canada’s largest mental health and addiction teaching hospital, as well as one of the world’s leading research centres in its field. CAMH combines clinical care, research, education, policy development and health promotion to help transform the lives of people affected by mental health and addiction issues. CAMH is fully affiliated with the University of Toronto, and is a Pan American Health Organization/World Health Organization Collaborating Centre. For more information, please follow @CAMHnews and @CAMHResearch on Twitter.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to related to data presented at the 25th World Congress of Psychiatric Genetics meeting in Orlando, Fla.; GeneSight testing being able to statistically significantly improve generalized anxiety disorder treatment response and decrease benzodiazepine use; the study providing strong evidence that the GeneSight test can help physicians personalize treatment for patients with anxiety, leading to more effective treatment and a beneficial reduction in benzodiazepine use; and the Company’s strategic directives under the caption “About Myriad Genetics.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.