Myriad Genetics has announced compelling new evidence supporting the clinical utility of its GeneSight Psychotropic test for treating major depressive disorder (MDD), with two significant studies demonstrating improved patient outcomes and faster treatment response times.
Meta-Analysis Shows Superior Clinical Outcomes
A comprehensive meta-analysis of six prospective controlled studies involving 3,532 adults with major depressive disorder revealed substantial improvements when clinicians had access to GeneSight test results. Compared to treatment as usual (TAU), patients in the GeneSight-guided treatment arm demonstrated:
- 41% higher likelihood of achieving remission
- 30% higher likelihood of achieving response
The meta-analysis focused on patients who had experienced at least one prior treatment failure, using widely recognized depression assessment tools including the Hamilton Depression Rating Scale (HAM-D17) and the Patient Health Questionnaire (PHQ-9). Response was defined as a 50% or greater improvement in depression scores from baseline to endpoint, while remission was defined as a score of seven or less on the HAM-D17 or five or less on the PHQ-9.
"This meta-analysis summarizes the clinical evidence of the GeneSight test, demonstrating superiority over treatment as usual-which often involves repeated medication trials," said Sagar V. Parikh, M.D., FRCPC, study author and professor of psychiatry at the University of Michigan. "This study found that the GeneSight test can be a powerful tool to augment a clinician's knowledge, experience and passion for their patients' recovery."
Faster Treatment Response Demonstrated in PRIME Care Analysis
A post-hoc analysis of the Precision Medicine in Mental Health Care (PRIME) study, the largest pharmacogenomic randomized controlled trial in mental health, provided additional evidence of the test's clinical benefits. The analysis of 1,764 veteran patients showed that those receiving GeneSight test-guided treatment were:
- 27% more likely to achieve remission from depression at any given time during the 24-week study period
- 21% more likely to experience response (at least a 50% reduction in depressive symptoms)
Importantly, these benefits persisted throughout the six-month study period with no evidence of diminishing effects over time.
"Every single day matters to someone suffering from depression; patients want to get back to feeling like themselves as quickly as possible," explained Dale Muzzey, PhD, chief scientific officer at Myriad Genetics. "As a result, a long trial-and-error period with medication can be frustrating for both clinicians and patients. This post-hoc analysis shows that treatment informed by the GeneSight test led to faster remission and response in patients with MDD – and this benefit lasted for at least six months."
Clinical Significance and Public Health Impact
The original PRIME Care study, published in the Journal of the American Medical Association (JAMA) in 2022, enrolled 1,944 U.S. Veterans with depression and met both of its prespecified primary outcomes. Patients in the pharmacogenomic-guided arm were less likely to be prescribed antidepressant medications with significant gene-drug interactions and were 28% more likely to achieve remission across the 24-week trial duration.
"Depression is not just a mental health issue-it's a public health priority," said Muzzey. "If we want to improve overall outcomes and enhance quality of life, we must treat depression with the same urgency and resources as any other chronic condition. This meta-analysis adds to our confidence in the clinical validity and utility of the GeneSight test."
Test Technology and Applications
The GeneSight Psychotropic test analyzes how a patient's genetic makeup may impact their metabolism and response to more than 60 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. The test is designed to provide clinicians with information that may help reduce the trial-and-error process often associated with psychiatric medication prescribing.
Myriad Genetics plans to submit both sets of data to payers as part of ongoing efforts to increase patient access to the GeneSight test and help patients achieve remission from depression more effectively.
