Assurex Health, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN), today announced that results from a large, well-controlled pharmacogenomics study in patients with major depressive disorder (MDD) were presented at the American Psychiatric Association annual meeting in New York City. The key finding is that patients were 50 percent more likely to achieve remission and 30 percent more likely to respond to treatment when their medication selection was guided by the GeneSight Psychotropic genetic test.
“We now have the results from the largest-ever pharmacogenomics clinical study in patients with moderate-to-very severe depression,” said Bryan Dechairo, Ph.D., executive vice president of clinical development, Myriad Genetics. “The important news here is that when doctors used the GeneSight genetic test to guide their selection of antidepressants, patients experienced significantly higher rates of response and remission as well as better overall symptom relief.”
This 24-week landmark study included 1,167 patients with moderate-to-very severe depression who had failed at least one antidepressant medication. Patients were divided into two treatment arms: the GeneSight Psychotropic test arm (n=560) in which clinicians used GeneSight test results to guide treatment decisions and a treatment-as-usual arm (n=607) in which psychiatrists and primary care physicians prescribed medication as they normally would without the benefit of genetic testing. The Hamilton Depression scale (HAM-D17) was used to measure the key endpoints of remission (achieving a HAM-D17 score <7), response (50 percent decrease in HAM-D17 from baseline) and symptom improvement (percent change in HAM-D17 from baseline) at week 8. The durability of patients’ mental health outcomes was assessed at week 24.
The study provides useful information in determining the value of psychotropic genetic testing. An article by NBC New in 2015 https://www.nbcnews.com/better/wellness/new-psychiatric-dna-testing-unpr... cited a failure and a success of GeneSight. It also pointed out the lack of data available to determine genetic testing's ability to improve outcomes.
GeneSight is a 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.