MASON, Ohio, May 4, 2014 /PRNewswire/ -- Assurex Health today announced an enhancement of its GeneSight® Psychotropic test, providing clinicians with the most comprehensive genetic-based tool available to help them make individualized antidepressant and antipsychotic medication decisions for patients with depression, anxiety, post-traumatic stress disorder (PTSD), bipolar disorder, schizophrenia and other behavioral health disorders. GeneSight Psychotropic now covers 38 FDA-approved medications, including recently approved levomilnacipran (Fetzima®) and vortioxetine (Brintellix®).
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).i 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, depression remission rates vary from 30 to 45 percent, and up to a third of SSRI-treated patients develop recurrent depression symptoms while on therapy.ii Low rates of symptom improvement resulting from trial-and-error prescribing of these medications can be frustrating - and even life threatening - for patients.
"Our mission is to help clinicians improve patient outcomes," said James S. Burns, Chief Executive Officer of Assurex Health. "We are committed to being the leader in neuropsychiatric pharmacogenomics and will incorporate proven genetic variants and new medications as they become available. GeneSight is clinically validated to help improve patient outcomes, leading to earlier identification of optimal treatment for individual patients and will continually be at the forefront of making healthcare better for clinicians and patients."
GeneSight Improves Responses, Lowers Health Care Costs
"GeneSight Psychotropic is now the only test to integrate scientifically validated drug response and metabolism genes, including CYP3A4, for a broad range of psychiatric medications into an easy-to-interpret report for clinicians to see which medications may be optimal for individual patients," 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."
"GeneSight Psychotropic has peer reviewed proof of its positive impact on patients' treatment outcomes; the newly expanded GeneSight Psychotropic test is expected to further improve individualized patient medication selection," notes Dechairo.
Compared with current standards of care, patients whose treatment was guided by GeneSight Psychotropic experienced a 70 percent greater improvement in depressive symptoms, according to a peer-reviewed 2013 study published in Pharmacogenetics and Genomics.iii 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.iv This can reduce health care costs by as much as 38 percent. v
"Pharmacogenomic and pharmacokinetic assessments are now available to aid clinicians seeking precision treatments for depression, and the science is rapidly expanding," said John F. Greden, M.D., Executive Director of the University of Michigan Comprehensive Depression Center, the Rachel Upjohn Professor of Psychiatry and Clinical Neurosciences in the Department of Psychiatry, and Founding Chair of the National Network of Depression Centers (NNDC). "Clinical validation of the GeneSight pharmacogenomics test is impressive and, to my knowledge, one-of-a-kind in this space. To accelerate clinical applications, numerous NNDC members are now engaged in getting more experience with its applications."
Eight Genes, 38 Drugs, Over 785,000 possible medication calls per patient
The enhanced GeneSight Psychotropic test now includes two additional genes involved in metabolizing psychotropic medications, CYP3A4 and CYP2B6, to measure a greater percent of genetic variance in drug metabolism. Notably, GeneSight Psychotropic is the first and only psychiatric pharmacogenomic test to offer CYP3A4 analysis distinct and separate from CYP3A5. The CYP2B6 gene accounts for up to 10 percent of the liver's vital drug metabolizing role, including bupropion (Wellbutrin®), the third most commonly prescribed antidepressant.
By integrating these data -- a patient's unique genetic profile and the pharmacology of the 38 available medications -- GeneSight Psychotropic analyzes more than 785,000 possible gene-drug combinations to generate personalized patient reports. The results are available to the ordering clinician via a secure web portal within 36 hours after Assurex Health receives a patient's cheek swab sample.
Specifically, the individualized patient report places FDA-approved antidepressants and antipsychotic medications into three color-coded categories: "Use as Directed" in green, "Use with Caution" in yellow, or "Use with Increased Caution and with More Frequent Monitoring" in red. The report alerts clinicians to the implications of the genetic information as it relates to dosage, pharmacology, FDA-approved package insert information, as well as detailed information on medication metabolism and mechanisms of actions.
"Antidepressants and antipsychotic drugs take time to deliver an effect, so individualized information that helps us make a good treatment decision for each patient sooner improves patient care," said John Gelinas, Jr., MD, President and Medical Director of Family Study Center, Inc. in Danbury, CT. "Because I have to make medication changes or additions for some patients, understanding what drugs are likely to have an effect alone or in combination is very useful. I have found that the GeneSight Psychotropic test has helped me improve treatment decisions and reduce side effects for my patients."
Mental Health: A Significant Concern in the U.S.
An estimated 25 percent of U.S. adults have a mental illness and nearly half will develop at least one during their lifetime, the CDC reports.vi The effects range from minor daily living disruptions to incapacitating personal, social and occupational impairments and premature death, which the CDC estimates will tally at least $300 billion annually, including about $193 billion from lost earnings and wages, $24 billion in disability benefits, and $100 billion in healthcare.vii
About GeneSight
GeneSight Psychotropic is one of four Assurex Health products powered by GeneSight technology. GeneSight ADHD provides information about patient response to ADHD medications, including stimulant and non-stimulant medications, and GeneSight MTHFR helps determine if additional folic acid supplementation is necessary. Assurex Health also recently announced a significant upgrade to GeneSight Analgesic giving physicians a powerful genetic-based tool to help evaluate responses for patients with acute or chronic pain to 22 medications in four drug classes: opioids, NSAIDs, muscle relaxants and opioid dependency (for more information, visit:http://assurexhealth.com/pr-analgesic/). GeneSight results are available 36 hours after Assurex Health receives a patient's cheek swab sample and are provided in an easy-to-read, actionable composite report for healthcare providers to quickly determine which medications are genetically appropriate for an individual patient.
GeneSight's efficacy and economic utility are validated in four peer-reviewed published clinical studies which together document that patients being treated for depression are greater than two times more likely to respond when physicians use GeneSight to guide their treatment. More than 8,000 healthcare practitioners have used GeneSight to guide treatment decisions for over 80,000 patients. Many commercial and government insurance plans reimburse all or part of the cost of GeneSight. In addition, Assurex Health offers financial assistance programs for patients who qualify.
About Assurex Health
Assurex Health is a personalized medicine company dedicated to helping clinicians determine the right medication for individual patients with neuropsychiatric and other medical conditions. Assurex Health's proprietary technology is based on pharmacogenomics - the study of the genetic factors that influence an individual's response to medication treatments - as well as evidence-based medicine and clinical pharmacology. The company was founded to commercialize industry-leading personalized medicine technology for neuropsychiatric disorders. Assurex Health has licensed patented technology from Mayo Clinic and Cincinnati Children's Hospital Medical Center. For more information about Assurex Health, please visit www.assurexhealth.com.
i CDC, http://www.cdc.gov/nchs/data/databriefs/db76.pdf
ii 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 http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0046379/pdf/TOC.pdf April 23, 2014. Page ES-1.
iii 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
iv Meta-analysis of prospective studies shows improved antidepressant efficacy and predicted outcomes. Poster presentation. International College of Neuropsychopharmacology. Jerusalem, Israel; April 2013.
v Winner,J. (2013). Psychiatric pharmacogenomics predicts health resource utilization of outpatients with anxiety and depression. Transl. Psychiatry, 3:e242.
vi CDC, http://www.cdc.gov/mmwr/preview/mmwrhtml/su6003a1.htm's_cid=su6003a1_w
vii CDC, http://www.cdc.gov/mmwr/preview/mmwrhtml/su6003a1.htm's_cid=su6003a1_w
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