New Analysis of GUIDED Trial Shows GeneSight Test Results Led to Statistically Significant Improvements in Remission, Response and Symptoms
SALT LAKE CITY, Nov. 06, 2019 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN, “Myriad” or the “Company”), a global leader in molecular diagnostics and precision medicine, today announced that a new analysis of the GUIDED1 clinical trial was published online in The Journal of Clinical Psychiatry. The key finding is that the GeneSight® Psychotropic test improved clinical outcomes – remission, response and symptoms – in patients taking medications with gene-drug interactions. Improvement in all three endpoints was statistically significant.
“Treatment decisions for people with major depressive disorder are challenging, particularly for patients who have already not benefitted from one or more medications,” said Michael E. Thase M.D., lead author and professor of psychiatry, Perelman School of Medicine, University of Pennsylvania. “In some cases, nonresponse or intolerance to a standard antidepressant can result from a gene-drug interaction. When that’s the case, you want to select a different medication that doesn’t have that interaction.”
Patients enrolled in the GUIDED clinical trial were diagnosed with major depressive disorder (MDD) and had failed at least one psychotropic medication. Patients were randomized to treatment as usual (TAU) or the guided-care arm in which clinicians had access to the GeneSight test report to inform their medication decisions. The analysis published in the Journal of Clinical Psychiatry today evaluated a total of 787 people from the GUIDED clinical trial who were taking medications with gene-drug interactions at baseline as identified by the GeneSight test.
The results from the analysis showed that people in the GeneSight arm (n=357) achieved statistically significant improvements in all clinical outcomes compared to TAU (n=430) at week 8 (Figure 1).
To view Figure 1: GeneSight Provided Significant Improvements in All Patient Outcomes, please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/c936641a-599d-4e45-bcfd-3efa8ea48cad
Importantly, the improvements in all clinical outcomes were durable and continued throughout the six-month follow up period. Remission increased 82 percent, response rates increased 64 percent and symptom improvement increased 56 percent from week 8 to week 24 (Figure 2).
To view Figure 2. GeneSight Clinical Benefits Were Durable and Improved Over Time, please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/9950226f-41f2-405d-958d-ad95f8152060
“Patient outcomes in the GeneSight-guided arm were superior to treatment-as-usual. Additionally, patients continued to get better over time and the rate of remission, which is the goal of treatment, nearly doubled from week 8 to week 24,” said Dr. Thase. “Too often patients with difficult-to-treat depression relapse, and this data shows that the patient benefits in the GeneSight-guided arm were durable.”
The new analysis also assessed how the GeneSight test impacted outcomes for patients who were taking medications with gene-drug interactions at baseline and who switched medications, which was defined as dropping at least one medication and adding at least one different medication. Among people who switched, all clinical outcomes were statistically significantly better for those in the GeneSight arm (n=235) compared to TAU (n=225) at week 8, underscoring the value of using combinatorial pharmacogenomic information to help inform treatment decisions (Figure 3).
To view Figure 3. GeneSight Improved Outcomes for Patients Switching Medications, please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/429f2e06-f03d-4a20-bc3e-17b330940cf5
“The GeneSight test identified patients taking medications with gene-drug interactions, and physicians were able to use this information to switch patients to medications with fewer gene-drug interactions and improve their outcomes,” said Michael R. Jablonski, Ph.D., vice president of Medical Affairs, Myriad Neuroscience. “This is an important first step in the journey towards making precision medicine a reality for people suffering from depression.”
About GeneSight® Psychotropic
GeneSight Psychotropic is a pharmacogenomic test that analyzes clinically important variations in DNA. The results of the test can inform doctors about genes that may impact how their patients metabolize or respond to depression medications.
About Myriad Genetics
Myriad Genetics Inc., is a leading precision 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 critical success factors: 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, Prolaris, ForeSight and Prequel 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 combinatorial pharmacogenomic testing augmenting physician decision-making and helping people get well; making precision medicine a reality for people suffering from depression; 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 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; 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, 2019, 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.