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Sundance Diagnostics Developing Antidepressant Suicide Risk Test
Date:12/12/2013

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. 

(Photo: http://photos.prnewswire.com/prnh/20131212/AQ32409)

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. 

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SOURCE Sundance Diagnostics, Inc.
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