Mason, OH - December 1, 2015 - Assurex Health, Inc. today announced a significant enhancement to its GeneSight® Psychotropic test giving healthcare providers an expanded range of options in helping to make medication decisions for patients suffering from depression, anxiety, bipolar disorder, posttraumatic stress disorder (PTSD), schizophrenia, and other behavioral health conditions.
With the addition of two new drug classes, 17 FDA-approved medications and four clinically-validated genes, GeneSight Psychotropic now covers 97 percent of prescriptions written to treat depression, anxiety, bipolar disorder and schizophrenia. GeneSight Psychotropic uses a patient's own genetic makeup to determine which medications may be most or least effective for that patient.
GeneSight Psychotropic is the most comprehensive neuropsychiatric pharmacogenomics test available on the market: 1) it's the only one that uses combinatorial pharmacogenomics, 2) has the most clinical data supporting its clinical validity and utility, 3) includes more relevant genes than its competition, and 4) analyzes the most relevant medications and drug classes that cover neuropsychiatric disorders.
"Assurex Health's addition of more medicines, new relevant genes and enhanced reporting makes GeneSight Psychotropic the best-in-class tool to assist healthcare providers in choosing genetically appropriate medications for their patients. It is invaluable when selecting a medication, changing dose, or augmenting therapy," said Assurex Health CEO Gina Drosos. "By enhancing the science underlying the GeneSight test, Assurex Health can improve health outcomes and provide cost savings for patients, providers, and payors."
Powered by CPGxTM, a proprietary combinatorial pharmacogenomics technology, the GeneSight test measures multiple genomic variants for each patient and weights them together - rather than one at a time - to provide comprehensive genetically-driven information for each medication for each patient in an actionable, easy-to-interpret report. Using GeneSight to guide treatment decisions has proven to reduce annual healthcare costs by over $2,500 per patient per year. According to a 2015 peer-review study, medication costs were reduced by more than $1,000 per year per patient. Use of GeneSight also significantly improved patients' adherence to their prescribed treatments and reduced the number of medications patients were co-prescribed, according to the study. Another study demonstrated that following GeneSight to guide treatment decisions reduced healthcare utilization costs by $1,500 per patient per year due to a decrease in total healthcare visits, fewer medical absence days, and fewer disability claims.
Many commercial and government insurance plans, including Medicare and the U.S. Department of Veterans Affairs, reimburse all or part of the cost of GeneSight. Assurex Health also offers financial assistance programs for patients who qualify.
GeneSight Psychotropic Test Now Includes 55 Medications
The GeneSight Psychotropic test adds four medications known as mood stabilizers, which are used to treat patients diagnosed with bipolar disorder; 12 anxiolytic and hypnotic medications, which are used to treat patients with anxiety; and one new antipsychotic medication.
With these additions, GeneSight is the only test that evaluates 55 medications from six drug classes using validated, peer-reviewed data regarding responses of 12 key genes involved in drug metabolism as well as how the body responds to drugs.
GeneSight Psychotropic Report Classifies Medications Based on Gene Interactions
GeneSight Psychotropic now analyzes more than 18,247,680 permutations of an individual's gene-drug interactions, including four newly added genes, UGT1A4, UGT2B15, HLA-B*1502, and HLA-A*3101, in addition to the genes already included, CYP2D6, CYP2C19, CYP2C9, CYP1A2, CYP2B6, CYP3A4, SLC6A4, and HTR2A.
"GeneSight Psychotropic is another step on our journey to bring mental wellness to those who are struggling with neuropsychiatric challenges," said Bryan Dechairo, Ph.D., Senior Vice President, Medical Affairs and Clinical Development at Assurex Health. "The new GeneSight report presents healthcare providers with even more comprehensive test results, is easier to read, and includes specific drug-gene interactions."
GeneSight results, available 36 hours after Assurex Health receives a patient's cheek swab sample from a healthcare provider, are provided in an easy-to-read actionable report. Specifically, the report places medications into three color-coded categories based on the patient's genetic profile: "Use as Directed" in green, "Moderate Gene-Drug Interaction" in yellow, or "Significant Gene-Drug Interaction" in red.
The report also alerts healthcare providers to the clinical implications of genetic information on dosage and provides detailed information on medications' metabolism (pharmacokinetics) and on medications' effects on the body (pharmacodynamics).
GeneSight Psychotropic is one of four pharmacogenomic tests available from Assurex Health, including GeneSight ADHD, GeneSight Analgesic, and GeneSight MTHFR.
Anxiety Disorders and Bipolar Disorders Prevalence in U.S.
Anxiety disorders are the most common mental illness in the U.S., affecting 40 million adults in the United States age 18 and older. Only about one-third of those suffering anxiety disorders receive treatment, despite being highly treatable. Patients with anxiety disorders annually cost the U.S. more than $42 billion, more than one quarter of the country's $148 billion total mental health bill.
Bipolar disorder affects approximately 5.5 million Americans age 18 or older, or 2.6 percent of the adult population. An estimated 51 percent of individuals with this condition are untreated in any given year. Suicide is the number one cause of premature death among people with bipolar disorder, with 15 percent to 17 percent taking their own lives as a result of negative symptoms that come from untreated illness.
About Assurex Health
Assurex Health is a commercial-stage, informatics-based precision medicine company providing treatment decision support to healthcare providers for behavioral health and chronic pain conditions. We help people achieve mental wellness with advanced CPGx™, a proprietary combinatorial pharmacogenomics technology providing individualized treatment support for neuropsychiatric conditions.
Assurex Health is the leader in neuropsychiatric combinatorial pharmacogenomics. It was founded in 2006 with licensed, patented technology from Mayo Clinic and Cincinnati Children's Hospital Medical Center, who continue to be research collaborators. Assurex Health is the only company in the category with multiple peer-reviewed, published studies that demonstrate the clinical validity and clinical utility of its technology, including its substantial healthcare cost savings benefit. The company has grown every quarter, and also has begun to expand internationally through a partnership with Canada's Centre for Addiction and Mental Health (CAMH).
NDTI Audit, September 2015
Winner JG, et. al., "Combinatorial pharmacogenomic guidance for psychiatric medications reduces overall pharmacy costs in a 1 year prospective evaluation," Curr Med Res Opin. 2015 Sep;31(9):1633-43. doi: 10.1185/03007995.2015.1063483. Epub 2015 Jul 23. https:/
Winner J, Allen JD, Altar CA, Spahic-Mihajlovic A. Psychiatric pharmacogenomics predicts health resource utilization of outpatients with anxiety and depression. Transl Psychiatry. 2013 Mar 19;3:e242. doi: 10.1038/tp.2013.2.
Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence, severity, and comorbidity of twelve-month DSM-IV disorders in the National Comorbidity Survey Replication (NCS-R). Archives of General Psychiatry, 2005 Jun;62(6):617-27.
The Economic Burden of Anxiety Disorders," a study commissioned by ADAA (The Journal of Clinical Psychiatry,60(7), July 1999).