Genetic test may predict drug-induced suicide
Last Updated: 16:13 December 12, 2013
Boulder-based Sundance, headed by chief executive Kim Bechthold, has entered a 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 the diagnostic test.
The test is to enable physicians to decrease the risk of suicide in patients treated with single antidepressant drugs and combinations of psychiatric medications.
The Max Planck scientific team was led by Drs. Andreas Menke and Elisabeth Binder. The scientists discovered 79 genetic markers that had a 91 percent probability of correctly classifying patients at risk of antidepressant-induced suicide in an independent study.
"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," Bechthold said.
Sundance is preparing for the launch of the product as a laboratory developed test in the United States and Europe and will announce in early 2014 when it will be available.
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.
According to IMS Health, there are more than 9 million new patient prescriptions written each year in the United States. An additional 9 million new patient prescriptions are estimated to be written yearly worldwide.
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