2,000 Patient Study Will Leverage GeneSight Test to Guide Therapy Selection
SALT LAKE CITY, Nov. 10, 2017 – Assurex Health, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today announced that the Department of Veterans Affairs (VA) recently initiated a national, multi-center trial to evaluate the company’s GeneSight® test to help improve health outcomes for veterans diagnosed with major depressive disorder (MDD). Approximately 20 percent of the 2.6 million veterans who deployed to Iraq or Afghanistan returned with MDD or a related mental health condition, and tragically suicide rates for veterans are twice that of the United States population.
“Through this study we hope to learn if there is an association between the GeneSight test and more effective treatment for Veterans suffering from major depressive disorder, a condition which affects many veterans,” said David Oslin, M.D., principal investigator and chief of Behavioral Health at the Corporal Michael J. Crescenz VA Medical Center. “As the largest healthcare provider in the U.S., the VA is committed to improving mental health care for our nation’s Veterans and reducing the suicide rate for Veterans. We’re excited to incorporate pharmacogenomic testing into our Prime Care study to help tailor treatment plans for our Veterans with the goal of improving their health outcomes.”
The study titled, PRIME Care (PRecision Medicine In MEntal Health Care), is a randomized clinical trial to determine how providers use and patients respond to GeneSight-guided therapy. The VA has committed $12 million to fund the study that will enroll 2,000 patients with MDD and include 250 healthcare providers at 21 VA medical centers. The study is expected to complete in 2021. Full details of the trial are available at: www.clinicaltrials.gov (NCT03170362).
“We are extremely honored to collaborate with the VA by providing our high quality GeneSight pharmacogenomics test to the PRIME Care study and to support the VA’s mission to care for America’s veterans,” said Bryan Dechairo, Ph.D., executive vice president, Clinical Development, Myriad Genetics. “As one of the largest healthcare providers worldwide, the VA is uniquely positioned to use genetic information to improve the treatment of major depression.”
About the Prime Care Study
The purpose of this study is to determine the effectiveness of providing Veterans suffering from depression, and their providers, the results of pharmacogenomic testing for psychotropic medications. The study focuses on whether and how patients and providers use genetic test results given to them at the time an antidepressant is to be initiated to treat Major Depressive Disorder (MDD) and whether use of the test results improves patient outcomes. MDD is one of the most common conditions associated with military service and combat exposure, increases suicide risk, and worsens the course of common medical conditions, making it a leading cause of disability and mortality. Validation of a pharmacogenomic testing to personalize the treatment of MDD represents an important opportunity to improve the healthcare of Veterans. Veteran recruitment is taking place at 21 different VA Sites. Click here watch a video about the study: Introduction to Pharmacogenetics: PRIME Care Study.
About the Department of Veterans Affairs
The VA is the second largest Federal agency with close to 300,000 employees. The Department’s mission is to serve America’s veterans and their families with dignity and compassion and to be their principal advocate in ensuring that they receive the care, support and recognition earned in service to this Nation.
About The GeneSight® Test
The GeneSight test helps healthcare providers make better treatment decisions based on a person’s genetic makeup. GeneSight testing is based on advanced CPGx® technology, a patented approach that analyzes variations and combinations of a person’s genes along with FDA-approved medications for behavioral health conditions and chronic pain. Peer-reviewed, published studies have proven its clinical benefits and substantial healthcare cost savings. More than 18,000 healthcare professionals have used GeneSight with over 500,000 patients. Learn more at www.GeneSight.com.
About Assurex Health
Assurex Health, a wholly-owned subsidiary of Myriad Genetics, Inc., is an informatics-based, personalized medicine company providing treatment decision support to healthcare providers for behavioral health and chronic pain conditions. Assurex Health is the only company in the category with multiple peer-reviewed, published studies that demonstrate the clinical validity and clinical utility of the GeneSight® test, including its substantial healthcare cost savings benefit. The Company has grown every quarter and has expanded internationally through a partnership with Canada’s Centre for Addiction and Mental Health (CAMH). For more on how Assurex Health is helping people gain mental wellness, visit www.AssurexHealth.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 three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, 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, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight 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 relating to the Company’s collaboration with the Department of Veterans Affairs (VA) regarding a national, multi-center trial to evaluate the Company’s GeneSight® test to help improve health outcomes for veterans diagnosed with major depressive disorder (MDD); the size, scope, timing and outcome of the study; leveraging the GeneSight test to guide therapy selection in the study; whether there is an association between the GeneSight test and more effective treatment for Veterans suffering from major depressive disorder; incorporating pharmacogenomic testing into the Prime Care study to help tailor treatment plans for our Veterans with the goal of improving their health outcomes; the VA’s financial commitment to fund the study; the number of patients with MDD to be enrolled in the study; the number of health care providers and VA medical centers to be utilized in the study; the expected completion date of the study; 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 our 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 Annual report on Form 10-K for the fiscal year ended June 30, 2016, 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.