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Assurex Health Releases Enhanced Pharmacogenomic Test to Help Clinicians Select Medications for Depression, Anxiety and PTSD

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Assurex Health recently 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). 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. 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. 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. This can reduce health care costs by as much as 38 percent.

“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. 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.

Source: Assurex Health