Salt Lake City– Myriad Genetics, Inc. (NASDAQ:MYGN), a worldwide leader in personalized medicine, today announced that results from the Individualized Medicine: Pharmacogenetics Assessment and Clinical Treatment (IMPACT) study were published in the Journal of Psychiatric Research. The study evaluated 1,871 patients with moderate-to-severe depression who met the overall study criteria. The goal of the study was to compare patient outcomes based upon ordering physician type in patients whose therapy selection was aided by the GeneSight® test.
The study found that the outcomes were strong regardless of provider type, and the patients seen by primary care physicians actually improved the most. Importantly, the patients treated by primary care physicians compared to psychiatrists saw 27 percent greater improvement in depressive symptoms, 35 percent higher rates of response, and 63 percent higher rates of remission (Table 1).
Table 1: Clinical Outcomes from the IMPACT Study at Week 8 by Ordering Physician Type
Outcome Primary Care
Improvement 31.7% 24.9% 27% <0.01 27.2%
Rates 30.1% 22.3% 35% <0.01 26.0%
Rates 19.5% 12.0% 63% <0.01 15.3%
* The landmark GUIDED study was presented at the American Psychiatric Association annual meeting in May 2018.
“The first physicians to typically treat patients with major depression are primary care physicians so it is critical that they have access to advanced technologies that can help patients as early as possible,” said Bryan M. Dechairo, Ph.D., executive vice president of Clinical Development at Myriad Genetics. “The IMPACT study demonstrates that primary care physicians when aided by the GeneSight test can achieve excellent patient outcomes that were better than what was seen in the recent GUIDED prospective clinical study.”
Individualized Medicine: Pharmacogenetic Assessment & Clinical Treatment (IMPACT) is a research study conducted by the Tanenbaum Centre for Pharmacogenetics at the Centre for Addiction and Mental Health (CAMH), which uses the GeneSight genetic test to determine specific enzymes and genes related to medication action. The goal of this research study is to achieve more effective therapies by incorporating genetic information.
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. The National Institute of Mental Health estimates 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.
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 visit www.genesight.com.
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.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore 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.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the IMPACT study demonstrating that primary care physicians when aided by the GeneSight test can achieve patient outcomes that were better than what was seen in the recent GUIDED prospective clinical study; and the Company’s strategic directives under the captions “About GeneSight,” and “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 set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in 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 and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; 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; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; 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 or other intellectual property; 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; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2017, 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. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.