Sundance Diagnostics, an organization that develops genetic tests to predict personal risk of medication side effects, recently announced that the organization has entered into an exclusive, worldwide licensing agreement with the Max Planck Institute of Psychiatry, Munich, Germany. This agreement sets out 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.
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.
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 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.
Eleven percent of Americans over the age of 12 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.