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 StudyThe 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® TestThe 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 HealthAssurex 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 GeneticsMyriad 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.
Media Contact:Ron Rogers(801) 584-3065rrogers@myriad.com
Investor Contact:Scott Gleason(801)
584-1143sgleason@myriad.com
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