NEW YORK (GenomeWeb News) – Sundance Diagnostics today announced an exclusive, worldwide licensing deal with the Max Planck Institute of Psychiatry aimed at developing and commercializing a genetic test for predicting the risk of suicide from use of antidepressants.
Sundance will validate and commercialize the test, which is based on a set of biomarkers discovered by researchers at Max Planck. The Boulder, Colo.-based company plans to launch the test as a laboratory-developed test in the US and Europe and will provide an update on its availability in early 2014.
It also will conduct clinical studies in preparation of a submission for regulatory clearance by the US Food and Drug Administration, European CE marking, and insurance reimbursement, Sundance said, adding it plans to submit applications to regulatory agencies within 18 months.
Andreas Menke and Elisabeth Binder led the team at Max Planck that conducted the research on the markers. They discovered 79 genetic markers that showed a 91 percent probability of correctly classifying patients at risk of antidepressant-associated suicide in an independent replication 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," Sundance CEO Kim Bechthold said in a statement.