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Extensive Scientific Data Supports the Clinical Validity of Pharmacogenomic Testing for Predicting Patient Response to Psychiatric Medications
Date:10/28/2013

MASON, Ohio, Oct. 28, 2013 /PRNewswire/ -- Assurex Health, a leading personalized medicine company, announced today that the International Review of Psychiatry published an extensive review that validates the clinical use of pharmacogenomic testing to help predict patient response to psychiatric medications and improve treatment outcomes. The paper provides substantial evidence that psychiatric pharmacogenomic testing has proven clinical value in predicting how individual patients will tolerate and respond to specific psychiatric medications. These findings refute results of a previous assessment of pharmacogenomic testing conducted in 2007 by the Evaluation of Genomic Applications in Practice and Prevention initiative (EGAPP) which concluded that there was insufficient evidence to determine the value of pharmacogenomic testing for adults beginning treatment with SSRI antidepressants.

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The current article titled "Clinical Validity of Cytochrome P450 Metabolism and Serotonin Gene Variants in Psychiatric Pharmacotherapy"* reviewed published data collected since 2007 examining how DNA sequence variations between individuals can affect their metabolism and response to medications.  The preponderance of evidence from these studies supports the validity of analyzing patients' genetic profile to predict the metabolism, safety, and therapeutic efficacy of psychotropic medications commonly used for the treatment of depression, schizophrenia, and bipolar disorder.    

"A review of 294 scientific studies published since the EGAPP report clearly demonstrates the clinical validity of multiple genes in predicting patient responses to antidepressant medications.  This assessment is further supported by multiple clinical trials demonstrating that understanding variations in these same genes leads to better treatment decisions and better patient outcomes," said C. Anthony Altar, Ph.D., Chief Science Officer of Assurex Health and lead author.   

"The review of these clinical and scientific data clearly reinforces the benefits of pharmacogenomic testing in aiding medication selection and augmenting patient responses to antidepressant and antipsychotic medications. Use of pharmacogenomic testing leads to earlier identification of optimal treatment protocols for individual patients," said Assurex Health CEO James S. Burns.  "The question is no longer whether pharmacogenomic testing is ready for routine clinical use; rather, how to make it available earlier in the course of patient treatment to improve patient outcomes."   
  
About the Publication   

The authors conducted a systematic literature review to assess whether pharmacokinetic (PK) or pharmacodynamic (PD) responses to 26 commonly prescribed antidepressant and antipsychotic medications, including efficacy or side effects, are associated with nucleotide polymorphisms in eight commonly studied genes in psychiatric pharmacotherapy.  Of the 294 publications reviewed, a majority showed significant associations between polymorphisms and patient response to psychotropic medications.  In many cases, a lack of association was traced to inappropriate comparisons between a medication and the gene being evaluated.  The findings showed that combinatorial pharmacogenomic tests can help predict genetically appropriate medication choices and improve patient outcomes.      

*Authors of the article are: C. Anthony Altar, Ph.D., John Hornberger, M.D., M.S., Ashwini Shewade, M.S., M.Sc., Victor Cruz, B.S., Jill Garrison, M.S. and David Mrazek, M.D., FRC-Psych.  The review has been dedicated to the memory of David A. Mrazek, a pioneer in the theory and clinical application of psychiatric pharmacogenomics.   

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.  

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