BOULDER, Colo., Dec. 12, 2013 /PRNewswire/ -- Sundance Diagnostics announces they have entered into an exclusive, worldwide licensing agreement with the Max Planck Institute of Psychiatry, Munich, Germany, to expand the Institute's initial clinical validation of genetic markers and to commercialize a genetic test that predicts risk of suicide emerging from use of antidepressant drugs.
The test is to enable physicians to decrease the risk of suicide in patients treated with single antidepressant drugs and combinations of psychiatric medications.
According to IMS Health, there are over 9 million new patient prescriptions written each year in the U.S. An additional 9 million new patient prescriptions are estimated to be written yearly worldwide.
The company is preparing for the launch of the test as a laboratory developed test in the United States and Europe and will announce in early 2014 when it will be available. In addition, clinical studies will be initiated in support of a U.S. Food and Drug Administration submission for market clearance, European CE marking and insurance reimbursement. The company plans for applications to be submitted to the regulatory agencies within 18 months.
The Max Planck scientific team was led by Andreas Menke, M.D. and Elisabeth Binder, M.D. Ph.D. The scientists discovered 79 genetic markers that had a 91% probability of correctly classifying patients at risk of antidepressant-induced suicide in an independent replication study.
Of the 8.1% of patients who developed antidepressant-induced suicidality in the Institute's study, nearly 60% experienced the serious side effect within two weeks of beginning treatment.
Contrary to the current FDA warning that persons under the age of 25 have the greatest risk, study results indicated there was no age difference between those who developed suicidal ideation and those who did not. Scientists at the National Institute of Mental Health (NIMH), in their 1,900-patient STAR*D study, showed similar data.
Since 2005 all antidepressant drugs in the U.S., Canada and a number of European countries have carried the highest level warning for risk of suicide, but doctors have not been able to determine which patients may be at risk – sometimes with tragic results.
Sundance CEO Kim Bechthold stated, "Our hope is that the new test will assist the physician in significantly reducing the risk of these tragic results and will provide patients and families with valuable personal information to use with their doctors in planning treatment."
Eleven percent of Americans age 12 and over are reported to be taking an antidepressant drug in the CDC's National Health and Nutrition Examination Survey (NHANES). Antidepressant use increased 400% from the period 1988-1994 through 2005-2008, according to the National Center for Health Statistics.
The original research, "Genome-Wide Association Study of Antidepressant Treatment-Emergent Suicidal Ideation," was published online in Neuropsychopharmacology October 26, 2011.
The licensing agreement was concluded with Max Planck Innovation, the Max Planck Institute´s technology transfer organization.
Sundance Diagnostics' Chief Scientific Advisor is Peter Tolias, Ph.D., Professor and Director of the Stevens Institute of Technology, Center for Healthcare Innovation in Hoboken, New Jersey.
About Sundance Diagnostics
Sundance Diagnostics, based in Boulder, Colorado, is a diagnostic test developer focusing on genetic companion diagnostic tests to reduce the risk of serious side effects from major-market pharmaceutical medications. The company has assembled a group of leading scientific and medical experts in genetics, molecular diagnostics, psychiatry and neuropsychopharmacology.
About the Max Planck Institute of Psychiatry
The Max Planck Institute of Psychiatry in a unique way combines basic research, clinical research and patient care in the field of psychiatry and neurology. The main focus of research and clinical treatment options lies on depression and anxiety disorders. In the field of psychiatry, the Max Planck Institute of Psychiatry is regarded as one of the world-wide leading research institutes concentrating on the development of personalized medicine.
Press release contact:
CEO, Sundance Diagnostics
Phone: 303 862-2770
Max Planck Institute of Psychiatry contacts:
Dr. Dr. Elisabeth Binder
Managing Director, Max Planck Institute of Psychiatry, Department of Translational Research in Psychiatry and Stress-related Disorders
Phone: 49 89 30622-1
Dr. Andreas Menke
Scientist and Resident, Max Planck Institute of Psychiatry, Department of Translational Research in Psychiatry and Stress-related Disorders
Phone: 49 89 30622-1
|SOURCE Sundance Diagnostics, Inc.|
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