This announcement was issued by Assurex Health
Schizophrenia Patients Included for First Time in Study of
Mason, OH– October 16, 2014 - Assurex Health and Canada’s
Centre for Addiction and Mental Health (CAMH) today announced they have
received a $6 million grant from Genome Canada, an agency of the Canadian
government, to study the benefits of genetic testing to guide medication
decisions for patients with depression or schizophrenia.
The clinical trial is the first to evaluate Canadian
patients, including patients with schizophrenia, using personalized decision
guidance provided by the GeneSight® Psychotropic test, developed by Assurex
Health in Mason, Ohio.
The grant funds a joint Genomic Applications Partnership Program (GAPP)
to be managed by CAMH and Assurex Health, with administrative and programmatic
support from the Ontario Genomic Institute.
GeneSight technology is based on combinatorial
pharmacogenomics (CPGxTM),the study of how variations in multiple genes
influence an individual’s response to medications, as well as evidence-based
medicine and clinical pharmacology. The
technology analyzes response to medicines commonly prescribed to treat
depression and schizophrenia, as well as anxiety, posttraumatic stress disorder
(PTSD), bipolar disorder, and other behavioral health conditions.
Three Year Study to Examine Clinical Outcomes, Cost Benefits
is pleased to support this partnership that will accelerate the translation of
tailored treatments for mental health conditions, avoiding adverse drug
reactions. This in turn will reduce burden and cost to Canada's health care system,” said Dr. Pierre Meulien, President and CEO of Genome Canada.
The study, “Clinical Utility and Enhancements of a
Pharmacogenomic Decision Support Tool for Mental Health Patients,” will be
funded over three years. Assurex Health and CAMH investigators, working with
clinicians from the greater Toronto
area, will conduct a 12week randomized and blinded study with Canadian patients
diagnosed with depression or schizophrenia. Healthcare providers of patients in
both disease categories for whom prior prescription drug treatment has failed will
receive personalized guidance for medication selection and dosing using the
GeneSight Psychotropic test.
“The study will also evaluate the ability of genetic
variants discovered at CAMH to predict important side effects of psychiatric
medications, and will collect economic data on how testing impacts health care
costs,” said C. Anthony Altar, PhD, Senior Vice President, Neurosciences of
Assurex Health and co-principal investigator on the grant. “We will look at how
prescribing more appropriate medications specifically suited to individual
patient’s genetics correlates to clinical outcomes and cost benefits.”
Clinical improvements will be compared among three groups:
patients whose healthcare providers receive the GeneSight Psychotropic report,
patients whose healthcare providers receive a variation of the GeneSight report
enhanced with genetic variants discovered at CAMH, and patients who are treated
as usual, without the benefit of guidance by either of the GeneSight tests.
“The new study, generously supported by the GAPP award, will
provide a clear picture of how pharmacogenomic medication guidance may help
Canadian patients, and will enhance the science behind tests like GeneSight,”
said Dr. James L. Kennedy, Director of Molecular Science in CAMH’s Campbell
Family Mental Health Research Institute and co-principal investigator on the
Multiple clinical studies published in peer-reviewed
journals in the U.S. have demonstrated the clinical validity, utility, and
economic benefits of the GeneSight test in making decisions about treating
patients with major depression, compared with treatment as usual.[i],[ii]This
strong data is driving growing reimbursement coverage.
Study Conducted at 10 Sites with 1,200 Patients
This is the first clinical study of this type conducted in Canada. The
trial will be conducted at 10 sites throughout Ontario,
primarily in Toronto,
and will include 1,200 patients.
In any given year, one in five Canadians experiences a
mental health or addiction problem.[iii]
Mental illness is the second leading cause of disability and premature death in
The economic burden of mental illness in Canada is estimated at $51 billion
per year. This includes health care costs, lost productivity, and reductions in
health-related quality of life.[v]
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The Centre for Addiction and Mental Health (CAMH) is Canada’s largest mental health and
addiction teaching hospital, and one of the world’s leading research centers in
this field. CAMH combines clinical care, research, education, policy
development and health promotion to help transform the lives of people affected
by mental illness and addiction. CAMH is fully affiliated with the University of Toronto, and is a Pan American Health
Organization/World Health Organization Collaborating Centre. http://www.camh.ca
About Assurex Health
Assurex Health is the leading personalized medicine company providing
industry-leading treatment decision support to clinicians for behavioralhealth and chronic pain conditions. Assurex Health’s
proprietary technology is based on combinatorial pharmacogenomics (CPGxTM) –
the study of how variations in multiple genes influence an individual’s
response to medications – as well as evidence-based medicine and clinical
pharmacology. Assurex Health has licensed patented technology from Mayo
Clinic and Cincinnati Children’s Hospital
who remain technology collaborators. For more information, visit www.assurexhealth.com.
GeneSight helps health care providers make behavioralhealth and chronic pain
treatment decisions based on a patient’s unique genetic makeup. GeneSight
is the only neuropsychiatric pharmacogenomic test validated in multiple,
peer-reviewed, published clinical studies. GeneSight analyzes over 785,000
permutations of available medications based on an individual’s genetic profile,
and presents the results in an easy to read, actionable, color-coded report typically available 36 hours after Assurex
Health receives a patient's cheek swab. Learn more at www.genesight.com.
DeDiemar, Assurex Health
Byrne, Rick Miller Communications
[i] Hall-Flavin DK, Winner JG, Allen JD,
Carhart JM, Proctor B, Snyder KA, Drews MS, Eisterhold LL, Geske J, Mrazek DA.
Utility of integrated pharmacogenomic testing to support the treatment of major
depressive disorder in a psychiatric outpatient setting.Pharmacogenetics and
[ii]Winner JG, Carhart JM, Altar CA, Allen
JD, Dechairo BM. A prospective, randomized double-blind study assessing the
clinical impact of integrated pharmacogenomic testing for major depressive
disorder. Discovery Med. 2013;16(89): 219-227.
[iii]Smetanin et al. (2011). The
life and economic impact of major mental illnesses in Canada:
[iv]Institute of Health Economics (2008). How Much
Should We Spend on Mental Health?
[v]Dewa et al
(2008). A New Population-Based Measure of the Burden of Mental Illness in Canada.