Study showed PGx testing helps clinicians prescribe fewer medications with gene-drug interactions

Major Depressive Disorder (MDD) remission rates were significantly improved when clinicians had access to GeneSight® Psychotropic test results from Myriad Genetics, Inc. (NASDAQ: MYGN), according to a new nationwide study of nearly 2,000 veterans conducted by the U.S. Department of Veterans Affairs (VA).

The PRIME Care (Precision Medicine in Mental Health Care) study is the largest pharmacogenomic (PGx) randomized controlled trial (RCT) ever conducted in mental health. Results of the study were published in the July 2022 issue of the Journal of the American Medical Association (JAMA). The VA independently conducted and funded the study. Myriad Genetics provided the GeneSight tests for the study.

“The number of veterans suffering from depression is a serious mental health issue. The PRIME Care study showed that veterans are more likely to achieve depression remission when GeneSight test results are available to inform medication treatment,” said Paul J. Diaz, president and CEO, Myriad Genetics. “We thank the VA and the investigators for conducting this important research. The results demonstrate how veterans may be helped by clinicians who provide personalized medication treatment and how such treatment can help make a positive impact on their lives, their families’ lives, and their communities.”

In the PRIME Care study, 1,944 veteran patients with MDD received the GeneSight Psychotropic test and were randomized to receive results immediately (pharmacogenomic guided group) or after 24 weeks (usual care group). The study met its objective by achieving statistically significant results on both co-primary endpoints.

One co-primary endpoint showed that over 24 weeks, the pharmacogenomic guided group had a 28% greater likelihood (odds ratio = 1.28, 95% confidence interval 1.05-1.57, p=0.02) of achieving remission from MDD symptoms (defined as a score of five or less on the PHQ-9 depression symptom questionnaire). There were no identified harms from receiving GeneSight testing in the study.

“The VA PRIME Care Study further reinforces the body of evidence supporting the clinical utility of the GeneSight test as an important tool to inform medication selection in MDD treatment. The study showed a meaningful increase in remission rates for patients whose providers had access to GeneSight test results,” said Jay Elliott, vice president, medical affairs of mental health, Myriad Genetics. “Remission represents a reduction in symptoms and return to normal or near-normal function, which is considered the optimal treatment goal for both providers and patients.”

Another co-primary endpoint showed that patients in the usual care group were approximately two-fold more likely (odds ratio = 2.08, 95% confidence interval 1.52-2.84, p=0.005) to be prescribed medications with substantial predicted gene-drug interactions compared to the pharmacogenomic guided group in the first 30 days after randomization.

“Among patients with MDD, provision of pharmacogenomic testing for drug-gene interactions reduced prescription of medications with predicted drug-gene interactions compared with usual care,” according to the JAMA publication of the PRIME Care study.

“Major Depressive Disorder 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,” according to the VA PRIME Care study website. In fact, the VA estimates that one in eight to 10 veterans has major depression, requiring treatment with psychotherapy and/or antidepressants.1

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(1) U.S. Department of Veterans Affairs. https://www.research.va.gov/topics/depression.cfm

About the PRIME Care Study
The 24-week PRIME Care study was conducted among 1,944 Veterans who were diagnosed with Major Depressive Disorder at more than 20 VA Medical Centers around the country. The study focused 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 MDD and whether use of the genetic test results improves patient outcomes. Results were calculated at weeks four, eight, 12, 18, and 24.

The study was a two-arm, parallel-groups comparison of patient/provider dyads randomly assigned to receive the results of the GeneSight test at the time the planned treatment is initiated (intervention group) OR results returned after 24 weeks of treatment as usual (delayed results group).

The study incorporated a widely used depression questionnaire, the PHQ-9, to assess severity of depression symptoms. A score of five or less indicates remission of depression symptoms. Patients were required to have a score of nine or more on the PHQ-9 to enroll in the PRIME Care study.

About the GeneSight® Test
The GeneSight Psychotropic test from Myriad Genetics is the category-leading pharmacogenomic test for 64 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. The GeneSight test can help inform clinicians about how a patient’s genes may impact how they metabolize and/or respond to certain psychiatric medications. It is designed to provide information that may help avoid the trial-and-error process that often takes place when patients are prescribed certain mental health medications. Tens of thousands of clinicians have ordered the GeneSight test for more than 1.5 million patients in order to receive genetic information that is unique to each patient. GeneSight can be easily ordered by psychiatrists, general practitioners, nurse practitioners and other prescribers via a secure portal. The test can be administered in a home-based kit or a provider’s office using a simple cheek swab. GeneSight test results are typically provided in two days and supplement other information considered by a clinician as part of a comprehensive medical assessment. Learn more at GeneSight.com.

About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. Fast Company named Myriad among the World’s Most Innovative Companies for 2022. For more information, visit www.myriad.com.

Myriad, the Myriad logo, BRACAnalysis, BRACAnalysis CDx, Colaris, Colaris AP, MyRisk, Myriad MyRisk, MyRisk Hereditary Cancer, MyChoice CDx, Prequel, Prequel with Amplify, Amplify, Foresight, Precise, FirstGene, Health.Illuminated., RiskScore, Prolaris, GeneSight, and EndoPredict are trademarks or registered trademarks of Myriad Genetics, Inc. © 2022 Myriad Genetics, Inc. All rights reserved.

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