HomeNews & PressThird Clinical Study Confirms Treatment Guided By GeneSight Psychiatric Pharmacogenomics Test Third Clinical Study Confirms Treatment Guided By GeneSight Psychiatric Pharmacogenomics Test December 5, 2013News & Press 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. About GeneSight 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. Patient Hints To Help You Have A Better New Year The holidays have ended, and a new year has begun—a time when many embrace a fresh start by setting New Year’s resolutions. This year, why not consider s... Read more Patient Movement as Medicine: Solutions for Anxiety Moving forward. It sounds like a nice idea, especially when you’re feeling stuck deep in the throes of an anxiety spiral. But it turns out that physically m... Read more Patient Weight-Loss Drugs and Mental Health: What You Need to Know New medications for weight loss seem to be flying off pharmacy shelves these days. But could they be linked to mental health conditions? Researchers are ... Read more Patient 3 million patients (and counting!) have now taken the GeneSight test! We’re thrilled to share that 3 million patients (and counting!) have now taken the GeneSight test! We're so grateful to the dedicated healthcare providers who... Read more Patient The Model Minority Myth and Mental Health The model minority myth stereotypes one cultural group, typically Asian Americans, as “intelligent, hard-working, and diligent and therefore more academically, ... Read more Healthcare Provider How Clinicians Can Help Support Their Patients Who Are Being Bullied How Clinicians Can Help Support Their Patients Who Are Being Bullied Acts of bullying can cause feelings of fear, loneliness and sadness, as well as depressi... Read more Patient Cyberbullying: Unique Challenges and Impacts ‘We lost our daughter to cyberbullying.’ McKenna Brown was an accomplished hockey player and scholar, known for her kindness, when she became the target of int... Read more Going Beyond Green, Yellow, Red on the GeneSight Report This blog summarizes key points discussed during the March 2024 GeneSight® Engage webinar Participants: Bernie Ranchero, MD, MS, MBA, medical direc... Read more Healthcare Provider Top 5 Reasons Patients Stop Their Mood Disorder Treatment Mood disorder treatment for depression can be challenging – and patients may become frustrated when treatments don’t work. In fact, when people with depres... Read more Patient The Impact of Gratitude on Depression and Anxiety “Say ‘Thank you,” a mother reminds her young kiddo. “T.G.I.F.!” we cheer at the end of a long week. We know it’s important to be thankful. But do we ... Read more Patient The Silent Thief: The 5 Things Depression Can Steal “Depression is a thief,” writes Abhinav Chaurasia, a marketing automation specialist in an essay on LinkedIn. “It steals your joy, your motivation, and your abi... Read more Patient How to Talk to Your Doctor about Anxiety Medication “When I was 27, I felt bad all the time,” writes Joanna Goddard on the popular Cup of Jo blog. She describes her initial experience with anxiety in detail. ... Read more Healthcare Provider Building Trust by Reducing Bias: The GeneSight Test as a Tool for Mental Health Equity This blog summarizes key points discussed during Myriad Mental Health’s July 2022 Webinar: Building Trust by Reducing Bias: The GeneSight Test as a Tool for Men... Read more Patient Anxiety and older adults: What to look for and how to help “It’s not how old you are. It’s how you are, old.” - French author Jules Renard Mental health is important at every age. But when people experience an a... Read more Patient Adult ADHD: Symptoms, treatment, where to start Many people may incorrectly think ADHD, or attention-deficit/hyperactivity disorder, only impacts children. After all, according to the Centers for Disease C... Read more Healthcare Provider It’s time to talk suicide: addressing stigma around a difficult topic Trigger Warning: This webinar discusses suicide. If you or someone you know has suicidal thoughts, please call the National Suicide Prevention Lifeline at 988. ... Read more Patient Stress Relief Methods for Family Caregivers Caring for a loved one can be a rewarding and meaningful experience. However, the day in and day out of taking care of someone who is unwell also can be challen... Read more Healthcare Provider Healthcare Professional Burnout and Links to Depression When Dr. Lorna Breen, an ER doc in Manhattan, died by suicide in April 2020, it opened up a public discussion about the burdens faced by healthcare professi... Read more Healthcare Provider Antidepressant Withdrawal or Depression Reoccurrence? What Healthcare Providers Should Know People who stop taking antidepressants may do so for many reasons: they may feel like it isn’t working, may feel unable to cope with side effects, or may not fe... Read more Learn more Learn more about GeneSight How to talk to your provider View our clinical studies
Patient Hints To Help You Have A Better New Year The holidays have ended, and a new year has begun—a time when many embrace a fresh start by setting New Year’s resolutions. This year, why not consider s... Read more
Patient Movement as Medicine: Solutions for Anxiety Moving forward. It sounds like a nice idea, especially when you’re feeling stuck deep in the throes of an anxiety spiral. But it turns out that physically m... Read more
Patient Weight-Loss Drugs and Mental Health: What You Need to Know New medications for weight loss seem to be flying off pharmacy shelves these days. But could they be linked to mental health conditions? Researchers are ... Read more
Patient 3 million patients (and counting!) have now taken the GeneSight test! We’re thrilled to share that 3 million patients (and counting!) have now taken the GeneSight test! We're so grateful to the dedicated healthcare providers who... Read more
Patient The Model Minority Myth and Mental Health The model minority myth stereotypes one cultural group, typically Asian Americans, as “intelligent, hard-working, and diligent and therefore more academically, ... Read more
Healthcare Provider How Clinicians Can Help Support Their Patients Who Are Being Bullied How Clinicians Can Help Support Their Patients Who Are Being Bullied Acts of bullying can cause feelings of fear, loneliness and sadness, as well as depressi... Read more
Patient Cyberbullying: Unique Challenges and Impacts ‘We lost our daughter to cyberbullying.’ McKenna Brown was an accomplished hockey player and scholar, known for her kindness, when she became the target of int... Read more
Going Beyond Green, Yellow, Red on the GeneSight Report This blog summarizes key points discussed during the March 2024 GeneSight® Engage webinar Participants: Bernie Ranchero, MD, MS, MBA, medical direc... Read more
Healthcare Provider Top 5 Reasons Patients Stop Their Mood Disorder Treatment Mood disorder treatment for depression can be challenging – and patients may become frustrated when treatments don’t work. In fact, when people with depres... Read more
Patient The Impact of Gratitude on Depression and Anxiety “Say ‘Thank you,” a mother reminds her young kiddo. “T.G.I.F.!” we cheer at the end of a long week. We know it’s important to be thankful. But do we ... Read more
Patient The Silent Thief: The 5 Things Depression Can Steal “Depression is a thief,” writes Abhinav Chaurasia, a marketing automation specialist in an essay on LinkedIn. “It steals your joy, your motivation, and your abi... Read more
Patient How to Talk to Your Doctor about Anxiety Medication “When I was 27, I felt bad all the time,” writes Joanna Goddard on the popular Cup of Jo blog. She describes her initial experience with anxiety in detail. ... Read more
Healthcare Provider Building Trust by Reducing Bias: The GeneSight Test as a Tool for Mental Health Equity This blog summarizes key points discussed during Myriad Mental Health’s July 2022 Webinar: Building Trust by Reducing Bias: The GeneSight Test as a Tool for Men... Read more
Patient Anxiety and older adults: What to look for and how to help “It’s not how old you are. It’s how you are, old.” - French author Jules Renard Mental health is important at every age. But when people experience an a... Read more
Patient Adult ADHD: Symptoms, treatment, where to start Many people may incorrectly think ADHD, or attention-deficit/hyperactivity disorder, only impacts children. After all, according to the Centers for Disease C... Read more
Healthcare Provider It’s time to talk suicide: addressing stigma around a difficult topic Trigger Warning: This webinar discusses suicide. If you or someone you know has suicidal thoughts, please call the National Suicide Prevention Lifeline at 988. ... Read more
Patient Stress Relief Methods for Family Caregivers Caring for a loved one can be a rewarding and meaningful experience. However, the day in and day out of taking care of someone who is unwell also can be challen... Read more
Healthcare Provider Healthcare Professional Burnout and Links to Depression When Dr. Lorna Breen, an ER doc in Manhattan, died by suicide in April 2020, it opened up a public discussion about the burdens faced by healthcare professi... Read more
Healthcare Provider Antidepressant Withdrawal or Depression Reoccurrence? What Healthcare Providers Should Know People who stop taking antidepressants may do so for many reasons: they may feel like it isn’t working, may feel unable to cope with side effects, or may not fe... Read more