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Cincinnati Children's Issued Patent Covering Individualized Medication Dosing Technology
Date:12/2/2013

MASON, Ohio and CINCINNATI, Dec. 2, 2013 /PRNewswire/ -- Cincinnati Children's Hospital Medical Center (CCHMC) and Assurex Health today announced that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 8,589,175 encompassing the "Optimization and Individualization of Medication Selection and Dosing" by Cincinnati Children's inventors Drs. Tracy A. Glauser, Richard J. Wenstrup*, Alexander A. Vinks, and John P. Pestian. The CCHMC patent covers methods for optimizing dosing regimens for medications utilizing population models, genotype, and clinical information to treat patients with neuropsychiatric and other disorders.  Assurex Health is the exclusive worldwide licensee of the technology covered under the CCHMC patent and has developed pharmacogenomic tests for psychiatric, ADHD, and pain medications commercialized under the GeneSight® brand.

The Cincinnati Children's invention provides a mechanism for translating "one size fits all" drug dosing into individualized dosing based on a person's genetic and non-heritable characteristics. The methods of the invention can be applied to correct for the variability seen in drug metabolism due to genetic polymorphisms combined with the variability resulting from non-genetic factors. The results provide a way to standardize the impact of various fixed factors, such as a patient's genetic variability, and dynamic factors, such as drug-drug and drug-environment interactions or patient drug-adherence. As a result, the starting and target doses for neuropsychiatric and other medications can be determined without the need for metabolic data.

GeneSight is a unique pharmacogenomic treatment decision support tool that tests for clinically important genetic variants affecting a patient's response to neuropsychiatric medications. Prescribing a medication that may be more likely to succeed because it is tailored to an individual patient's genetic profile enables clinicians to better manage their patient's condition and improve outcomes. For example, the recently published La Crosse clinical study showed a four-fold greater improvement in symptoms for patients whose medications were switched from their initial medications that were genetically discordant with their GeneSight profile. Furthermore, physicians for 94% of the GeneSight-guided patients either switched their patients to genetically appropriate medications or adjusted their medication dosages according to the GeneSight report.

"The Cincinnati Children's patent represents a significant advance in pharmacogenomic-directed prescribing. The addition of dosing information to our GeneSight products will enhance their value as the premier treatment decision support products that help clinicians individualize the selection of psychotropic and other medications for their patients," said James S. Burns, CEO of Assurex Health. "Assurex Health was founded to develop and commercialize cutting-edge pharmacogenomic research at CCHMC. The issuance of this dose selection patent represents another milestone in translating state-of-the-art pharmacogenomic products to support the treatment of patients with neuropsychiatric and other disorders."

"Individualizing both the selection and dosing of medications will improve patient outcomes by providing objective, evidence-based information to tailor treatment programs," said Tracy A. Glauser, M.D., Associate Director, Cincinnati Children's Research Foundation and lead inventor on the CCHMC patent. "The issuance of this patent points to the importance of pharmacogenomic-directed prescribing and its potential to improve patient care in routine clinical practice."  

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. Cincinnati Children's has a financial interest in the technology referenced in this news release.

For more information about Assurex Health, please visit www.assurexhealth.com.

About Cincinnati Children's Hospital Medical Center
Cincinnati Children's Hospital Medical Center ranks third in the nation among all Honor Roll hospitals in the U.S. News and World Report's 2013 Best Children's Hospitals ranking. It is ranked #1 for cancer and in the top 10 for nine of 10 pediatric specialties. Cincinnati Children's, a non-profit organization, is one of the top three recipients of pediatric research grants from the National Institutes of Health, and a research and teaching affiliate of the University of Cincinnati College of Medicine. The Cincinnati Children's Research Foundation is one of the largest pediatric research centers in the nation, receiving over $150 million in grants annually and employs more than 500 faculty in over 50 academic departments. The medical center is recognized internationally for improving child health and transforming delivery of care through fully integrated, globally recognized research, education, and innovation. Additional information can be found at www.cincinnatichildrens.org.  Connect on the Cincinnati Children's blog, via Facebook and on Twitter. 

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.

* Richard J. Wenstrup currently serves as Chief Medical Officer at Myriad Genetics, Inc.


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