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U.S. Department of Veterans Affairs Awards GeneSight Federal Supply Schedule Contract

U.S. Department of Veterans Affairs Awards GeneSight Federal Supply Schedule Contract

Pharmacogenomic test now available to help guide clinicians’ medication decisions for veterans being treated for behavioral health conditions

Mason, OH – June 24, 2014.  Assurex Health today announced that the U.S. Department of Veterans Affairs (VA) has awarded a Federal Supply Schedule (FSS) contract as a government supplier, effective June 15, 2014, making the GeneSight® Psychotropic test available for use in VA facilities nationwide.  The Veterans Health Administration is America’s largest integrated health care system with more than 1,400 sites of care, serving almost nine million veterans each year.

GeneSight Psychotropic, developed by Assurex Health, analyzes how an individual’s genetic makeup affects response to a broad panel of medications prescribed for mental health conditions including depression, post-traumatic stress disorder, anxiety, bipolar disorder, and schizophrenia.

“Our mission is to help clinicians improve patient outcomes,” said Donald R. Wright, Chief Operating Officer of Assurex Health.  “Making the GeneSight Psychotropic test available to VA doctors to help guide patient medication and treatment decisions can make an enormous difference to veterans who need and deserve our help. We have a real opportunity to help doctors improve the lives of so many who have given so much for all of us.”

President Obama in 2012 signed an Executive Order directing the Departments of Veterans Affairs, Defense, and Health and Human Services, in coordination with other federal agencies, to take a number of steps to ensure that veterans, service members, and their families receive the mental health services and support they need. These steps included strengthening suicide prevention, enhancing access to mental health treatment and promoting development of more effective treatment methodologies.

“Aiding medication selection through GeneSight individualized testing for veterans, active duty personnel and their families with neuropsychiatric conditions is an important step toward improving their mental health care,” said James S. Burns, a veteran and Chief Executive Officer of Assurex Health.  “Assurex Health recognizes the needs of veterans and active duty personnel who have served in Iraq and Afghanistan, as well as the many veterans from earlier conflicts who suffer from PTSD and/or depression.”

The VA FSS (V797D-40187) approval will also allow clinicians in the Department of Defense, the Bureau of Indian Affairs, and the Federal Bureau of Prisons to have access to the GeneSight Psychotropic test.

Depression is a Major Personal and Economic Burden

At least 20 percent of Iraq and Afghanistan veterans have PTSD and/or depression, according to a RAND Center for Military Health Policy Research study.i  The study also found that health care for a veteran with PTSD costs 3.5 times as much as for one without the disorder. Individual treatment costs about $8,300 per patient per year.

In the private sector, ineffective treatment for depression is responsible for more than 200 million days lost from work in the U.S. each year. Depression, particularly treatment resistant depression, exacts a substantial toll on patients’ quality of life and adds $106-$118 billion in societal costs including healthcare utilization, workplace productivity and crime.ii Clinically validated treatment decision support to improve outcomes has been used by thousands of clinicians as an improvement to current prescribing practices.

Antidepressants are the most commonly prescribed medications taken by Americans aged 18 to 44, according to the U.S. Centers for Disease Control and Prevention (CDC).iii While selective serotonin reuptake inhibitors (SSRIs) are frequently used as first-line treatment for depression, response to treatment rates vary from 40 to 60 percent and depression remission rates vary from 30 to 45 percent.iv An estimated one-third of those studied in the NIH STAR*D trial failed to respond after multiple treatment augmentations, thus meeting criteria for “Treatment Resistant Depression.”v  Low rates of symptom improvement resulting from trial-and-error prescribing of these medications can be frustrating – and even life threatening – for patients.

GeneSight Guided Treatment Improves Response, Lowers Health Care Costs

“Multiple peer-reviewed and published clinical studies have demonstrated the validity and utility of GeneSight,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health.  “Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient’s genetic profile can help clinicians better manage each patient’s disorder and improve clinical outcomes.”

Compared with usual treatment, patients whose medication selection was guided by GeneSight Psychotropic experienced a 70 percent greater improvement in depressive symptoms, according to a peer-reviewed 2013 clinical study published in Pharmacogenetics and Genomics.vi  Additionally, patients whose healthcare providers used GeneSight to help guide antidepressant treatment experienced double the rate of both remission and response compared with treatment as usual, based on a meta-analysis of three clinical studies presented at the 2013 meeting of the International College of Neuropsychopharmacology.vii Getting patients on genetically appropriate medications can reduce health care costs by as much as 38 percent.viii

“GeneSight is a powerful tool for clinicians making treatment decisions,” said John F. Greden, M.D., Founding Chair of the National Network of Depression Centers (NNDC); Executive Director, University of Michigan Comprehensive Depression Center; Past President, Board of Directors, American Foundation for Suicide Prevention; and a former Army physician. “Those who have served our country deserve perhaps more than anyone to have their clinicians adopt the new technologies that will help them deliver personalized treatments and lessen subsequent complications of mood disorders.”

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 neuropsychiatric disorders. The results of the GeneSight report can help a clinician understand the way a patient’s unique genomic makeup may affect certain neuropsychiatric medications. 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.

Assurex Health has four laboratory developed tests powered by GeneSight technology.  The GeneSight Psychotropic test analyzes how a patient’s genes may affect his/her metabolism and response to FDA-approved medicines commonly prescribed to treat depression, anxiety, bipolar disease, schizophrenia or other behavioral health conditions.  GeneSight Analgesic gives physicians a powerful genetic-based tool to help evaluate medication responses for patients with acute or chronic pain across four medication classes: opioids, NSAIDs, muscle relaxants and opioid dependency. GeneSight ADHD provides information about patient response to ADHD medications, including stimulant and non-stimulant medications. GeneSight MTHFR helps determine if additional folic acid supplementation is necessary. More than 8,000 healthcare practitioners have used GeneSight to guide treatment decisions for over 90,000 patients.  For more information, visit GeneSight.com.

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 with neuropsychiatric and other medical conditions. The company was founded to commercialize industry-leading personalized medicine technology for neuropsychiatric conditions.  Assurex Health has licensed patented technology from Mayo Clinic and Cincinnati Children’s Hospital Medical Center. For more information, visit www.assurexhealth.com. Assurex Health is a DBA of AssureRx Health, Inc.

Note: The Federal Supply Services (FSS) contract makes the GeneSight Psychotropic test available to be ordered by clinicians for veterans and select other federal employees.  It does not imply a Department of Veterans Affairs endorsement, and this press release is neither paid for nor sponsored, in whole or in part, by any element of the United States Government.

[i] RAND Center for Military Health Policy Research, “Invisible Wounds of War: Psychological and Cognitive Injuries, Their Consequences, and Services to Assist Recovery,”  Edited by Terri TanielianLisa H. Jaycox  https://www.rand.org/content/dam/rand/pubs/monographs/2008/RAND_MG720.sum.pdf

[ii] A Review of the Clinical, Economic, and Societal Burden of Treatment-Resistant Depression: 1996–2013 David A. Mrazek, M.D.; John C. Hornberger, M.D., M.S.; C. Anthony Altar, Ph.D.; Irina Degtiar, B.A., B.S. Psychiatric Services 2014; doi: 10.1176/appi.ps.201300059

[iii] CDC, https://www.cdc.gov/nchs/data/databriefs/db76.pdf

[iv] McMaster University Evidence-based Practice Center. “Comparative Effectiveness Review, Number 62, Treatment for Depression After Unsatisfactory Response to SSRIs,” U.S. Agency for Healthcare Research and Quality Publication No. 12-EHC050-EF, April 2012.  Accessed at https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0046379/pdf/TOC.pdf April 23, 2014.  Page ES-1.

[v] Hall-Flavin, D. (2013). Utility of integrated pharmacogenomic testing to support the treatment of major depressive disorder in a psychiatric outpatient setting.  Pharmacogenetics and Genomics, 23(10), 535-548. doi: 10.1097/FPC.0b013e3283649b9a https://www.ncbi.nlm.nih.gov/pubmed/24018772

[vi] Meta-analysis of prospective studies shows improved antidepressant efficacy and predicted outcomes. Poster presentation. International College of Neuropsychopharmacology. Jerusalem, Israel; April 2013.

[vii] Winner,J. (2013). Psychiatric pharmacogenomics predicts health resource utilization of outpatients with anxiety and depression. Transl. Psychiatry, 3:e242. https://www.ncbi.nlm.nih.gov/pubmed/23511609