New Results from the IMPACT Study to be Presented at the American Society of Clinical
Psychopharmacology (ASCP) Annual Meeting
SALT LAKE CITY, May 31, 2018 (GLOBE NEWSWIRE) -- Assurex Health, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN), today announced that results from the Individualized
Medicine: Pharmacogenetics Assessment and Clinical Treatment (IMPACT) study will be highlighted at the 2018 ASCP annual meeting in
Miami Beach, Fla.
The key finding is that patients with depression whose medication selection was guided by the GeneSight® Psychotropic genetic test saw improvements in remission,
response and symptoms when treated by both primary care physicians and psychiatrists. Additionally, patients treated by
primary care physicians exhibited 33 percent more symptom improvement, 34 percent increased response and 57 percent greater
remission than those treated by psychiatrists.
“Most patients with depression are treated by primary care providers who select antidepressant medications using a trial and
error approach,” said Bryan Dechairo, Ph.D., executive vice president of Clinical Development, Myriad Genetics. “The IMPACT
study demonstrated the clinical value of the GeneSight test to guide medication selection in the primary care setting and achieve
better outcomes for patients.”
The study data are summarized below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about conference news
and updates by using the hashtag #ASCP18.
Title: Pharmacogenomics and Depression Symptom Improvement: Treatment by Primary Care Physicians or
Psychiatrists.
Presenter: Julie-Anne Tanner, Ph.D., Assurex Health and Centre for Addiction and Mental Health.
Date: Thursday, May 31, 2018, 12:30 – 2:00 p.m. EDT.
Location: Poster T24.
This study evaluated the clinical utility of the GeneSight test in selecting medications for 2,025 patients with
moderate-to-severe major depressive disorder who were enrolled in the IMPACT study. All patients were assessed using the Beck
Depression Inventory (BDI) at baseline (Day 0) and follow up (Week 8-12) to measure symptom improvement, response and
remission. The findings were reported according to provider type (i.e., primary care vs. psychiatrist).
The overall results demonstrated that when clinicians used the GeneSight test results to guide medication selection, patients
saw a 28 percent mean reduction in symptoms (p<0.01). Additionally, 26 percent of patients responded to treatment and 17
percent achieved remission, which is consistent with previously reported studies. Importantly, there were significantly
greater improvements for patients treated by primary care providers versus psychiatrists (Graph 1). Specifically, there was a
33 percent improvement in symptoms (p<0.01), 34 percent improvement in response (p<0.01) and 57 percent improvement in
remission (p<0.01).
A graph accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/1cb636d4-aa11-47d8-af21-56e2ed206b1a
“In this study, the pharmacogenetic testing helped both psychiatrists and primary care providers achieve better outcomes for
their patients, and the greatest improvements were observed in the primary care setting,” said James L. Kennedy, M.D., lead
investigator and head of the Tanenbaum Centre for Pharmacogenetics at the Centre for Addiction and Mental Health in Toronto.
“The significant factor in these differences across care settings may be that psychiatrists frequently care for more complex
patients who may have more difficult to treat depression. Importantly, these results strongly support expanding the use of
pharmacogenetic testing to patients who are treated by primary care providers.”
The IMPACT study results are consistent with a landmark GeneSight study presented earlier this month at the American Psychiatric Association
annual meeting in New York City. That study showed that GeneSight guided therapy resulted in a 50 percent improvement in
remission and a 30 percent improvement in response versus treatment as usual at week 8.
About IMPACT
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 Depression
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 16.2 million adults in the United States had at
least one major depressive episode in the past year.
About 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 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: building 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: results from the IMPACT study being highlighted at the 2018 ASCP annual meeting; the
significant factor in the observed differences across care settings potentially being that psychiatrists frequently care for more
complex patients who may have more difficult to treat depression; the results strongly supporting expanding the use of
pharmacogenetic testing to patients who are treated by primary care providers; 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
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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, 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. 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.