GeneSight® Guided Treatment Significantly Improves Outcomes for Patients with Major Depression Treated in the Primary Care Setting

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 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, 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.

Media Contact: Ron Rogers
(908) 285-0248
rrogers@myriad.com
 Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
       

GeneSight® Guided Treatment Significantly Improves Outcomes for Patients with Major Depression Treated in the Primary Care Setting

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 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, 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.

Media Contact: Ron Rogers
(908) 285-0248
rrogers@myriad.com
 Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
       

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