GeneSight Psychotropic Test’s Combinatorial Approach Proves Better than Single-Gene Testing at Predicting Patient Outcomes and Medication Blood Levels

New Analysis Published in Psychiatry Research

SALT LAKE CITY, Feb. 08, 2021 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in genetic testing and precision medicine, announced today the peer-reviewed journal Psychiatry Research has published a new analysis showing the combinatorial approach available in the GeneSight^® Psychotropic test is better than single-gene testing at predicting patient outcomes and medication blood levels.

Myriad’s GeneSight test evaluates how variations in multiple genes may influence an individual’s outcomes with certain FDA-approved medications commonly prescribed to treat depression, anxiety, and other psychiatric conditions.

Using data from the Genomics Used to Improve DEpression Decisions (GUIDED) randomized-controlled trial, the study evaluated the ability of the combinatorial approach available in the GeneSight Psychotropic test to predict patient outcomes and medication blood levels compared to Clinical Pharmacogenetics Implementation Consortium^® (CPIC) single-gene recommendations. CPIC recommendations are based on either CYP2C19 and CYP2D6, which are genes that are involved in how the body metabolizes medications commonly used to treat depression and other mental illnesses.

The study included two types of analyses:

1. Patient Outcomes – The largest improvement in symptoms and the highest response and remission rates were observed for patients who were changed from medications with significant gene-drug interactions to medications with no or moderate gene-drug interactions indicated by the combinatorial GeneSight test.
2. Medication Blood Levels – The analysis of the combinatorial pharmacogenomic test and single-gene guidelines showed the predictive ability of the GeneSight combinatorial approach was better.

“Our analysis demonstrated the superior ability of combinatorial pharmacogenetic testing to predict variation in medication blood levels may result in improved patient outcomes,” said lead author Anthony J. Rothschild, MD, the Irving S. and Betty Brudnick Endowed Chair and Professor of Psychiatry at the University of Massachusetts Medical School. “We believe this study provides compelling evidence of the clinical validity of the combinatorial pharmacogenomic test for patients with major depressive disorder, who have at least one prior medication failure.”

“This analysis demonstrates that the combinatorial approach of the GeneSight test more accurately predicts blood drug levels and identifies more patients with significant gene-drug interactions who would be missed by single-gene testing,” said Dr. Mark Pollack, chief medical officer, Myriad Neuroscience. “Combinatorial pharmacogenomics like the GeneSight test should become the standard-of-care to help physicians understand gene-drug interactions that could improve care for people with depression, anxiety and other conditions.”

This is the second study evaluating the combinatorial approach of the GeneSight test to be published in Psychiatry Research. The earlier study, published in May 2020, demonstrated the combinatorial approach available in the GeneSight Psychotropic test was better at predicting citalopram and escitalopram blood concentrations when compared to single-gene testing.

The GUIDED study, the largest pharmacogenomic randomized controlled trial in mental health, showed that patients whose doctors received GeneSight results had significantly improved response and remission rates from depression, compared to treatment as usual.

About Myriad Neuroscience
Myriad Neuroscience is a business unit of Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine. Through its GeneSight^® Psychotropic test, Myriad Neuroscience provides information to healthcare providers about their patient’s genetic variations, which may impact how they metabolize or respond to certain psychiatric medications. Learn more at genesight.com/about-myriad-neuroscience/

About The GeneSight^® Test
Myriad’s GeneSight Psychotropic test is the category-leading pharmacogenomic test for depression medications. The GeneSight test can help inform doctors about genes that may impact how patients metabolize or respond to certain psychiatric medications. It has been given to more than one million patients by tens of thousands of clinicians to provide genetic information that is unique to each patient. It supplements other information considered by a doctor as part of a comprehensive medical assessment. Learn more at GeneSight.com.

About Myriad Genetics
Myriad Genetics Inc., is a leading genetic testing and precision medicine company dedicated to transforming patient lives worldwide. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. 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 CDx, Vectra, Prequel, Foresight, 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 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 set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; 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 decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); 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 most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, 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.