Third Clinical Study Confirms Treatment Guided By GeneSight Psychiatric Pharmacogenomics Test
Doubles Remission and Response Rate to Medications for Major Depressive Disorders
Mason, OH – December 5, 2013 – Assurex Health, a leading personalized medicine company, announced today the publication of a third clinical study providing evidence for the effectiveness of the GeneSight combinatorial pharmacogenomic test over the current method for selecting psychotropic medications. The study results were published in the November 2013 issue of Discovery Medicine. Consistent with two previous clinical trials, the Pine Rest study concluded that patients are more than twice as likely to respond when treatment is guided by GeneSight compared to treatment as usual. Importantly, GeneSight also identified 30% of patients with severe gene-drug interactions who had the greatest improvement in depressive symptoms when switched to medications concordant with their genetic profile.
The Pine Rest study was a prospective, double-blinded, randomized control trial (RCT) of antidepressant treatment response in subjects with a primary diagnosis of major depressive disorder followed over 10 weeks. Patients were blinded to their treatment group and depression severity was assessed by blinded study raters. Clinicians of patients in the guided group received the GeneSight report that categorizes psychotropic medications within a green, yellow or red “bin” based on the relationship of each medication to the patient’s combinatorial gene profile.
Patients in the pharmacogenomic-informed GeneSight group showed a greater than 2-fold likelihood of response and remission as compared with the treatment as usual (TAU) group who did not have the benefit of GeneSight results. Furthermore, 30% of patients in the TAU group were prescribed genetically discordant “red bin” medications. This group showed less than 1% improvement in depressive symptoms over the 10 week trial period. In contrast, the GeneSight group showed improved outcomes overall compared to current standard of care and greatest improvement in the 30% of patients previously taking genetically discordant medications. Based on objective genomic data, physicians for 100% of patients in the GeneSight-guided group used the report to either switch participants off medications discordant with their genetics to medications in the green bin or to adjust medication dosages versus only 50% of the physicians providing the typical standard of care.
“To my knowledge, this is the first real-world, double blind randomized control trial for pharmacogenomic intervention in psychiatry, making it an invaluable addition to the psychiatric literature,” said Joel G. Winner, M.D., Medical Director at Assurex Health. “The data in this paper align with our previous two published trials which show a doubling of response rate for major depressive disorder when the clinician uses GeneSight compared to those who did not use this integrated pharmacogenomic information.”
“The Pine Rest RCT replicated and reaffirmed the clinical validity of GeneSight by prospectively categorizing and predicting which patients receiving current standard of care would have high, medium or low response to treatment using our patented combinatorial pharmacogenomic GeneSight test and actionable green, yellow and red medication stratification report,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health.
These findings replicate results observed in two previous prospective joint clinical studies from Assurex Health and Mayo Clinic: the La Crosse Study published in Pharmacogenetics and Genomics (July 24, 2013) and the Hamm Study published in Translational Psychiatry (October 2012). La Crosse was a large prospective clinical trial involving 227 participants in which the GeneSight-guided group experienced an overall greater than 2-fold improvement in both symptoms and likelihood to achieve remission. All three studies consistently showed a substantially greater baseline to endpoint decrease in depressive symptoms with higher rates of response and remission in the guided GeneSight group over empiric prescribing, which is the current standard of care. These results reinforce the benefit of GeneSight in providing more objective, evidence-based support for clinicians in selecting medications for patients with psychiatric disorders.
About Assurex Health
Assurex Health is a personalized medicine company that specializes in pharmacogenomics and is dedicated to helping physicians determine the right medication for individual patients suffering from neuropsychiatric and other disorders. The company was founded to commercialize industry-leading personalized medicine technology for neuropsychiatric disorders. Assurex Health has licensed technology from Mayo Clinic and Cincinnati Children’s Hospital Medical Center. Mayo Clinic has a financial interest in the technology referenced in this news release.
For more information about Assurex Health, please visit www.assurexhealth.com.
GeneSight is a laboratory developed 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.